WORLD TRADE  
ORGANIZATION  IP/C/57 
10 December 2010 
 
 (10-6685) 
Council for Trade-Related Aspects of 
Intellectual Property Rights  
 
 
 
ANNUAL REVIEW OF THE DECISION  ON THE  IMPLEMENTATION OF  
PARAGRAPH 6 OF THE DOHA DECLARATION ON THE  
TRIPS AGREEMENT AND PUBLIC HEALTH 
 
Report to the General Council  
  1. Paragraph 8 of the Decision on the Implementati on of Paragraph 6 of the Doha Declaration on 
the TRIPS Agreement and Public Health of 30 August 2003 (the "2003 Decision") provides that the 
Council for TRIPS shall review annually the functioni ng of the System set out in the Decision with a 
view to ensuring its effective operation and shall annually report on its operation to the 
General Council.  This review is deemed to fulfil the review requirements of Article IX:4 of the WTO 
Agreement. 
2. The sixth annual review took place in October 2009 and the General C ouncil took note of the 
report of the Council for TRIPS (IP/C/53) at its  meeting on 17 December 2009 (WT/GC/M/124, 
paragraph 178).  The present report c overs the period since October 2009. 
3. At its meeting of 8-9 June 2010, the Council for TRIPS agreed to set aside the second day of 
its meeting of 26-27 October for the annual review.  The Annex to this report records the statements 
made in the review at the October meeting.  The paragraphs below set out factual information 
regarding the implementation and use of the 2003 Decision, discussions on the operation of the 
System and the acceptance of the Protocol Amending the TRIPS Agreement. 
1. Information on implementation and use of the System established under the Decision 
 
4. The following Members have formally notified the Council for TRIPS of the relevant changes 
to their domestic legal regime in order to implement the 2003 Decision:  
• Norway
 (see explanatory note in IP/C/W/427):  Amendments to the Patent Act of 
15 December 1967 No.9 and to Patent Regulations of 20 December 1996 No.1162 
provide the legal basis to act as an exporting Member;  
• Canada  (IP/N/1/CAN/P/5-7; see also explanatory note in IP/C/W/464):  Amendments to 
Patent Act and Food and Drugs Act, as well as the Use of Patented Products for 
International Humanitarian Purposes Regulations provide the legal basis to act as an exporting Member;  
• India
 (IP/N/1/IND/P/2):  the Patents (Amendment) Act 2005 provides the legal basis to 
act as an exporting Member;  IP/C/57 
Page 2  
 
  • European Communities
1 (IP/N/1/EEC/P/5):  Regulation (EC) No 816/2006 of the 
European Parliament and of the Council of 17 May 2006 on Compulsory Licensing of Patents Relating to the Manufacture of Phar maceutical Products for Export to Countries 
with Public Health Problems provides the legal basis for EU Member States to grant compulsory licences for export of patented medicines;  
• Hong Kong, China
 (IP/N/1/HKG/P/1/Add.6;  see also background  information in 
IP/N/1/HKG/17):  the Patents (Amendment) Ordinance No.21 of 2007 provides the legal 
basis to act as exporting Member, as well as importing Member in situations of extreme urgency;  
• Switzerland
 (IP/N/1/CHE/P/9 and IP/N/1/CHE/4):  the consolidated version of the 
Federal Law on Patents for Inventions of 1 July 2008 and the Ordinance on Patents for 
Invention provide the legal basis to act as an exporting Member;  
• Philippines  (IP/N/1/PHL/I/10):  Republic Act No. 9502 (also known as the "Universally 
Accessible Cheaper and Quality Medicines Act 2008") and the Implementing Rules and 
Regulations of Republic Act No. 9502 provide th e legal basis for the grant of a special 
compulsory licence for the import of patented  drugs and medicines, as well as for their 
manufacture and export;  
• Singapore  (IP/N/1/SGP/P/1/Rev.1):  the Patent s Act 2005 Revised Edition provides the 
legal basis to act as an importing Member in situations of nationa l emergency or other 
circumstances of extreme urgency;  
 
• Albania  (IP/N/1/ALB/I/2): Law No.9947 of 7 July 2008 on Industrial Property provides 
the legal basis to act as an exporting Member;  
 
• Croatia  (to be circulated as IP/N/1/HRV/P/2):  the Act on Amending the Patent Act of 
2009 provides the legal basis to act as an exporting Member;  and  
 
• China  (to be circulated as IP/N/1/CHN/P/2): the amendment to the Patent Law of the 
People's Republic of China, which was adopt ed on 27 December 2008 and entered into 
force on 1 October 2009, provides the legal basi s to act as an exporting Member, as well 
as an importing Member in situations of national emergency or other circumstances of extreme urgency, or if public interest so requires.  
 
5. On 17 July 2007, the delegation of Rwanda subm itted a notification under paragraph 2(a) of 
the Decision, informing the Council for TRIPS of its intention to import a pharmaceutical product 
from Canada under the System (IP/N/9/RWA/1).  On 4 October 2007, the delegation of Canada 
notified the Council for TRIPS in accordance with  paragraph 2(c) of the Decision that it had 
authorized the manufacturing and export of the pha rmaceutical product concerned to meet Rwanda's 
                                                     
 
1 On 1 December 2009, the Tr eaty of Lisbon amending the Treaty on European Union and the Treaty 
establishing the European Community  (done at Lisbon, 13 December 2007) entered into force.  On 
29 November 2009, the WTO received a Verbal Note (WT/L/779) from the Council of the Eu ropean Union and 
the Commission of the European Communities stating that, by virtue of the Treaty of Lisbon , as of 
1 December 2009, the European Union replaces and succeeds the European Community.  IP/C/57 
 Page 3 
 
 
  needs (IP/N/10/CAN/1).  No notifications have been  made to the Council for TRIPS of the intention 
to use the System as an importer pursuant to paragraph 1(b) of the Decision.2 
6. Detailed information on the use of the System by Canada to ship a fixed-dose combination 
medicine for the treatment of HIV infection to Rw anda was provided by the delegation of Canada to 
the Council for TRIPS at its meeting on 2 March 2010 (IP/C/M/62, paragraphs 185-195;  for more 
details see also the Communication from the delegati on of Canada, IP/C/W/526, as well as reports in 
earlier annual reviews IP/C/53, paragraph 6; IP/C/4 9, paragraph 6; and IP/C /46, paragraphs 4-5). 
7. As foreseen in the 2003 Decision, the Secr etariat regularly updates a page on the WTO 
website dedicated to this Decision, notably to ensu re the public availability of notifications made 
pursuant to it (http://www.wto.org/English/tratop_e/public_health_e.htm). 
2. Discussion on the operation of the System established under the Decision 
8. In line with the decision taken by the Council fo r TRIPS at its annual re view in October 2009, 
the Chair held a round of informal consultations on the operation of the System on 12 February 2010. 
The Chair reported on the outcome of those consulta tions under the agenda item "Other Business" at 
the Council's formal meeting on 2 March 2010 (IP /C/M/62, paragraphs 168-175).  Subsequent 
discussions confirmed Members' readiness to shar e experiences on the use of the System and to 
engage in practical fact-based discussions in orde r to have a full understanding of its functioning 
(IP/C/M/62, paragraphs 176-212).  Members stat ed their substantive positions concerning the 
operation and review of the System.  Some delega tions expressed concern that the System had only 
been used once since 2003 and that it had taken so me three years to deliver the medicines from 
Canada to Rwanda in this context.  They also noted that only a limited number of Members had 
accepted the Protocol Amending the TRIPS Agreement (see the list of notified acceptances in Section 
3 below).  The delegation of Canada shared its experience in using the System, including a detailed 
timeline of events which, in its view, demonstrat ed the fact that Canada's Access to Medicines 
Regime (CAMR) had been successfully utilized and only a very small portion of the three year time 
period had been taken up by procedures associated with this regime. It said that much of the time that 
had elapsed between the regulatory review of the me dicine in question and the shipment to Rwanda 
could be attributed to other variables.  Other dele gations noted that the limited use of the System so 
far was not an appropriate measure of its success.  Its use in one case had demonstrated that it could work effectively and that the System could play a supportive role in the wider effort to improve access to essential medicines. 
9. Various issues were suggested for further discu ssion, but no agreement could be reached on 
the appropriate format for such discussions, beyond th e existing review process within the Council for 
TRIPS.  While agreeing that annual reviews cons tituted a good platform for sharing experiences and 
evaluating the operation of the System, some delegati ons proposed that the reviews could be usefully 
complemented by a dedicated workshop to allow fo r an in-depth study of any potential obstacles to 
the System's effective and exped itious operation.  In order to gather information on all aspects and 
concerns, the workshop should be open to all re levant stakeholders, including non-governmental 
organizations, pharmaceutical industr y and other experts.  Other de legations considered that the 
review process was a Member-driven process.  It al ready offered a platform to share experiences and 
to examine the System's functioning, and the initia l focus should be on Members reporting directly on 
their experience, positive or negative, with the Syst em.  While the usefulness of the existing review 
process could be enhanced, including through more fa ctual input, there was therefore no need to open 
                                                     
 
2 Least developed country Members automatically qualify as "eligible importing Member" under the 
System and are therefore exempted from  notifying the Council for TRIPS of th eir intention to use the System as 
importers. IP/C/57 
Page 4  
 
  a new process.  Given that at the March meeting the matter was raised under the agenda item "Other 
Business", the Council limited itself to taking note of the statements made. 
10. At the request of the delegations of Brazil, Ch ina, Cuba, Ecuador, India, Indonesia, Peru and 
Venezuela, an item on "Implementation of Paragr aph 6 System" was put on the agenda of the 
Council's meeting on 8-9 June 2010.  The Chair re ported on the consultations  he had held with 
interested delegations on how best to proceed with the preparations of the next annual review at the 
Council's meeting in October.  In subsequent discussions, delegations reiterated their positions 
regarding the format of future work in this  area (IP/C/M/63, paragraphs 184-247).  While no 
consensus could be reached on any complementary pr ocess, the Council agreed to set aside the second 
day of its meeting in October for the annual review  to enable a special focus on the issue, with 
possible involvement of health e xperts on national delegations.   
3. Decision on the Amendment to the TRIPS Agreement 
11. As called for in paragraph 11 of the 2003 Deci sion, the General Council adopted a Protocol 
Amending the TRIPS Agreement, by a Decision of 6 December 2005 (WT/L/641).  The Protocol is 
open for acceptance by Members until 31 December 2011 or such later date as may be decided by the 
Ministerial Conference (WT/L/785).  In accordance with Article X:3 of the WTO Agreement, the 
Protocol will enter into force upon acceptance by two thirds of the WTO Members. 
12. As of 30 September 2010, the following Members have notified their acceptance: 
• United States, 17 December 2005, WT/Let/506; 
• Switzerland, 13 September 2006, WT/Let/547; 
• El Salvador,  19 September 2006, WT/Let/548; 
• Republic of Korea, 24 January 2007, WT/Let/558; 
• Norway, 5 February 2007, WT/Let/563; 
• India, 26 March 2007, WT/Let/572; 
• Philippines, 30 March 2007, WT/Let/573; 
• Israel, 10 August 2007, WT/Let/582; 
• Japan, 31 August 2007, WT/Let/592; 
• Australia, 12 September 2007, WT/Let/593; 
• Singapore, 28 September 2007, WT/Let/594; 
• Hong Kong, China, 27 November 2007, WT/Let/606; 
• China, People's Republic of, 28 November 2007, WT/Let/607;  IP/C/57 
 Page 5 
 
 
  • European Communities3, 30 November 2007, WT/Let/608; 
• Mauritius, 16 April 2008, WT/Let/619; 
• Egypt, 18 April 2008, WT/Let/617;  
• Mexico, 23 May 2008, WT/Let/620;  
• Jordan, 6 August 2008,WT/Let/630; 
• Brazil, 13 November 2008, WT/Let/636; 
• Morocco, 2 December 2008, WT/Let/638; 
• Albania, 28 January 2009, WT/Let/639; 
• Macao, China, 16 June 2009, WT/Let/645; 
• Canada, 16 June 2009, WT/Let/646; 
• Bahrain, 4 August 2009, WT/Let/652; 
• Colombia, 7 August 2009, WT/Let/650; 
• Zambia, 10 August 2009, WT/Let/651; 
• Nicaragua, 25 January 2010, WT/Let/663; 
• Pakistan, 8 February 2010, WT/Let/664;  
• Former Yugoslav Republic of Macedoni a, 16 March 2010, WT/Let/671;  
• Uganda, 12 July 2010, WT/Let/678;  and 
• Mongolia, 17 September 2010, WT/Let/684. 
Information on the status of acceptances of the Prot ocol is periodically up dated in revisions of 
document IP/C/W/490. 
                                                      
3 The text of the instrument of acceptance reads as follows: 
 
"THE PRESIDENT OF THE COUN CIL OF THE EUROPEAN UNION, 
 
HAVING regard to the Treaty establishing the Europe an Community, and in particular Article 133(5) 
in conjunction with the first sentence of the first subparagraph of Article 300(2) and the second 
subparagraph of Article 300(3) thereof, 
 
NOTIFIES by these presents the acceptance, by the European Community, of the Protocol amending 
the Agreement on Trade-Related Aspects of Intellectua l Property Rights (TRIPS), done at Geneva on 
6 December 2005, 
 
CONFIRMS, in accordance with Article 300(7) of the Treaty establishing the European Community, 
that the Protocol will be binding on the Member States of the European Union. 
 
The Secretary-General/High Representative                The President of the Council 
      of the European Union" IP/C/57 
Page 6  
 
  ANNEX 
 
Excerpt from the Minutes of the Council's meeting
 
of 26-27 October 2010 to be circulated as IP/C/M/641 
 
 F. R
EVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 
 OF THE DOHA DECLARATION ON THE TRIPS  AGREEMENT AND PUBLIC HEALTH  
1. The Chairman  recalled that, at its meeting of 8- 9 June 2010, the Council for TRIPS had 
agreed to set aside the second day of the present me eting for the annual revi ew under paragraph 8 of 
the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement 
and Public Health ("the Decision").  In preparati on of the review, he had he ld consultations with a 
number of Members on how to structure the Council' s discussion in order to make the review as 
useful as possible.   In the light of those consulta tions, he had faxed a list of topics for discussion in 
the annual review to delega tions on 11 October.    
2. He further recalled that paragraph 8 of the Decision provided that the Council for TRIPS 
should annually review the functioning of the System set out in the Decision ("the System") with a view to ensuring its effective operation and re port on its operation to the General Council.   
Furthermore, the paragraph provided that this review should be deemed to fulfil the review 
requirements of Article IX:4 of the WTO Agreement.   
3. He said that the Secretariat had circulated a draft cover note for the Council's report modelled 
on previous years' reports (JOB/IP/1).  This  document contained factual information on the 
implementation and use of the System established under the Decision, on discussions held earlier in the year regarding its operation, and on the acceptance of the Protocol Amending the TRIPS Agreement.  In accordance with the way that the Council had prepared its reports in previous years, 
the part of the minutes of the meeting reflecting th e discussions held under this agenda item would be 
attached to the cover note as an annex. 
4. With respect to the status of acceptances of  the Protocol Amending the TRIPS Agreement 
that was done at Geneva on 6 December 2005, the Ch airman said that, since the Council's meeting in 
June 2010, Uganda and Mongolia had notified their acceptance of the Protocol on 12 July and 
17 September (documents WT/Let/ 678 and WT/Let/684, respectively).  So far 31 notifications of 
acceptance of the Protocol, including from the Eu ropean Communities, had been received.  The 
Secretariat had also circulated an update to the note on the status of acceptances of the Protocol 
(IP/C/W/490/Rev.7) which it would continue to upda te periodically.  The Protocol would enter into 
force for the Members that had accepted it upon acceptance of the Protocol by two thirds of the Members.  The Protocol was open for acceptance by Members until 31 December 2011 or such later 
date as might be decided by the Ministerial Conference. 
5. He said that he had prepared the list of topics for discussion in the annual review in the light 
of consultations he had held with a number of Memb ers.  He had made every effort to ensure that 
there were appropriate headings under which all the topics delegations had mentioned could 
adequately be discussed.  It was his hope that this way of structuring the discussion would ensure that 
the Council would have a productive and useful disc ussion of the System that would help it better 
understand its operation and any concer ns related to it.  Bearing in mind that Members had expressed 
interest in making the review as useful and produc tive as possible, he had encouraged them in the 
cover note to the fax to make introductory presentati ons under topics 1, 2 and 5.  He expressed his 
                                                     
 
1 The paragraph numbering of this excerpt will not co rrespond with that of the minutes of the TRIPS 
Council but has been included for the convenience of users.   IP/C/57 
 Page 7 
 
 
  appreciation to those delegations that had volunt eered to make introductory remarks under various 
headings, and also thanked the secretariats of UNCTAD, the WHO and WIPO, as well as of the WTO, for their willingness to contribute to the discussion. 
1. Experience of Members who have used or considered using the system 
6. The Chairman
 said that, in the Council's earlier discussions and his own consultations, 
Members had expressed an interest in hearing about the experience in the case of export of medicines 
from Canada to Rwanda, and also about the e xperience of any other Members who might have 
considered using the System as potential importers or exporters and reasons why the System had not 
been used.  In particular, Members had indicated th at they wished to better understand any obstacles 
or concerns about notifying their needs to the WTO, as well as any other obstacles or concerns faced 
by Members. 
7. The representative of Canada  recalled that the 2003 WTO Decision on TRIPS and Public 
Health was an intensely negotiated decision th at had garnered unanimous support from all WTO 
Members.  His delegation was very pleased with th is historic and multilateral solution.  It had 
implemented its Access to Medicines Regime (CAM R) in 2005 to facilitate the export of affordable 
generic drugs to developing countries.  It had also been the first, and to date only, WTO Member to 
ship generic medicines under the waiver.  An HIV antiretroviral drug – Apo-TriAvir – had been sent 
to Rwanda in two shipments by the Canadian  pharmaceutical company Apotex Inc. in 
September 2008 and 2009.  This example clearly show ed that Canada's regime and the System were 
efficient, effective and timely.   
8. He said that, in the Apotex-Rwanda example, the role of the Government of Canada and 
CAMR had been very limited in  the overall process.  This process could be divided into three 
components:  first, the issuance of an export auth orization under CAMR;  second, Apotex's role;  and 
third, Rwanda's own domestic requirements. 
9. Apotex had undertaken to develop Apo-TriAvir,  a new triple combination HIV/AIDS drug, 
before any recipient country had been identifie d, and had sought Health Canada's safety and 
efficiency review of the drug, as per CAMR's re quirement.  In December 2005, Health Canada had 
received a submission from Apotex to manufacture A po-TriAvir.  No recipient importing country had 
been identified at that point in time.  In June 2006 , Health Canada completed its review of Apotex's 
Apo-TriAvir submission, less than six months af ter it had been received, although CAMR would 
allow for a time-period of 12 months.   
10. After an eligible importing Member had identif ied its needs to the WTO, the CAMR process 
was completed in just over two months, starting w ith a request for voluntary licences and ending with 
the granting of the export authorization by means of  a compulsory licence.  On 13 July 2007, Apotex 
had sent letters to three pharmaceutical companies,  namely GlaxoSmithKlin e, Boehringer Ingelheim 
and Shire BioChem Inc., seeking voluntary licences to use their relevant patents to produce and export 
15,600,000 tablets of Apo-TriAvir to Rwanda.   
11. On 19 July 2007, Rwanda had notified the WTO of its intention to import 15,600,000 tablets 
of Apo-TriAvir under the waiver (IP/N/9/RWA/1).   On 4 September 2007, Apotex had filed an 
application with the Commissioner of Patents fo r authorization under CAMR to produce and export 
Apo-TriAvir to Rwanda.  On 19 September 2007, 15 days after receiving the application from 
Apotex, Canada's Commissioner of Patents had gr anted Apotex an authorization to produce and 
export Apo-TriAvir under CAMR.  Once such authoriza tion had been given, the role of the Canadian 
Government and CAMR in the process had been subs tantively complete.  On 4 October 2007, Canada 
had notified the WTO of the first authorization issued under the Waiver (IP/N/10/CAN/1).   IP/C/57 
Page 8  
 
  12. In October 2007, Rwanda had ope ned a public tender for the supply of Apo-TriAvir.  In 
May 2008, Apotex announced that it had won the Rwanda public tender to supply Apo-TriAvir.  
Apo-TriAvir had been manufactured by Apotex in May-September 2008, and in September 2008 
Apotex had sent its first shipment of 6,785,000 ta blets to Rwanda, followed by the second shipment of 
7,628,000 tablets in September 2009, completing the country's order.   
13. The representative of Canada said that in the Apotex-Rwanda case, CAMR represented a 
small part of the more than two years which had lapsed between the WTO notification by Rwanda and 
the final shipment by Apotex.  The shipments of Apo-TriAvir to Rwanda had occurred within the 
timelines specified in the export authorization that  had been granted by the Canadian Commissioner 
of Patents.  To evaluate CAMR and the System, it was necessary to return to the basic premises.  The 
purpose of the System and domestic implementation mechanisms, such as CAMR, was to ensure that 
TRIPS and patent rules did not prevent exports for humanitarian purposes of more affordable generic 
medicines to those countries that did not have manufacturing capacities. 
14. Taking into account his delegation's experience,  he concluded that CAMR or any similar 
exporting regime that a WTO Member implemented under the Waiver could only assist in supplying 
low-cost drugs if a demand was notified to the WTO by an eligible importing Member for generic 
drug(s) that required use of the System.  This w as a demand-driven process by countries in need, and 
only applied to instances where countries were seeking generic versions of patented drugs.  He noted 
that, since the adoption of the Decision in 2003, many options had become available to importing countries.  The international environment for procur ement of drugs had changed significantly with the 
introduction of a variety of global mechanisms and alliances which offered greater choice to countries 
to obtain medicines.  The role and effectiveness as  well as the potential for broader use of the Waiver 
needed to be understood in this broad global context.   
15. He said that the System had never been intende d to solve the issue of access to medicines on 
its own, but was seen as part of a broader inte rnational strategy to combat diseases impacting the 
developing world.  The System and CAMR functione d well.  They played a supporting role and were 
not a panacea to the challenges faced on global access to  medicines and were not designed to generate 
global supply. 
16. The representative of India
 presented some examples of cases in which there had been an 
attempt to use the Paragraph 6 System.  In Sept ember 2007, three applications under Section 92A of 
the Patents Act 1970 had been received for the gran t of a compulsory licence for the manufacture and 
export of patented drugs to a leas t developed country in Asia.  After the process envisaged under the 
Act had been initiated, the applicant had subse quently withdrawn the applications.  This had 
apparently been caused by the non-availability  of the corresponding compulsory licences or 
notifications from the importing country.  His delega tion had delved deeper in to the reasons for the 
withdrawal and had discovered that  one of the reasons was the additional burden of compliance with 
the conditions in paragraphs 2(a), (b) and (c) of  the WTO Decision, which included the notification 
requirements and anti-diversion measures.  He w ondered why such notification requirements were 
needed when they were not n eeded for a routine compulsory licence.  Moreover, the detailed 
requirements for suppliers to dis tinguish products produced under the System, such as pill colouring, 
labeling and website tracking did not only seem costly and time-consuming but were also a 
disincentive for generic producers. 
17. The System required notification to the WTO of both the quantity of the pharmaceutical 
products to be manufactured and the period of supp ly.  He said that ideally, when the quantity was 
specified, it should not be necessary to restrict th e period of supply, which would depend on a number 
of factors related to manufacture of medicines, quantity of shipment and trade.  If an additional quantity was required, the process had to be in itiated again, which was time-consuming.    IP/C/57 
 Page 9 
 
 
  18. He also reported that in 2004, the Doctors W ithout Borders (Médecins Sans Frontières, MSF) 
had attempted to place an order with the Canadi an company Apotex for a fixed-dose combination 
drug, but had found it too cumbersome and, after trying in vain for two years, had procured the generic version of the same fixed-dose combina tion drug, which had been WHO pre-qualified and 
reasonably priced, from two Indian generic companies. 
19. The representative of Brazil
 said that her country had not tried to use the System either as an 
importer or an exporter.  In 2007, following a case of abuse of price, a compulsory licence had been issued for an anti-retroviral medicine called Efavir enz that was part of the cocktail of drugs freely 
distributed by the Ministry of Health to HIV/AIDS  patients.  For a number of reasons, including lack 
of sufficient disclosure in the patents description, it had taken two years for the Oswaldo Cruz 
Foundation, an international refere nce institution in medical research in her country, to be able to 
produce the medicine.  During this time, Brazil had imported the medicine from a supplier in India. 
20. The representative of the United States
 asked whether Canada had carried out any activities to 
promote the waiver process and/or CAMR to poten tial importing countries and asked it to share any 
experiences in this regard. 
21. The representative of India  asked the delegation of Canada how much time it would take for 
CAMR processes to be completed the next time a request was submitted by a least developed country, counting from the receipt of the request, taking in to account the voluntary licence process, and ending 
with the grant of an export authorization.  Furthe rmore, his delegation's unde rstanding was that the list 
of products for which a compulsory licence could be  issued was set out in Schedule 1 of Canada's 
amended Patent Act which did not cover the full scope  of products envisaged by the Decision.  He 
asked whether this meant that the Decision could not be entirely implemented under Canadian law.  
He also inquired as to the status of Bill C- 393 to amend CAMR, and the issues which were under 
consideration and whether the amendment would completely address the limitations of CAMR.  As the Decision was sufficiently detailed, he asked w hy it was considered necessary to impose additional 
qualifications, such as the limited list of medici nes, the approval required from Health Canada, a 
two-year limit on compulsory licensing and the list of eligible countries.   
22. According to his information, Ghana had expressed an interest in 2005 in using CAMR in 
collaboration with two Canadian NGOs to import generics both for itself and as a regional importer 
for the ECOWAS countries.  It had even issued a regular compulsory licence in 2005.  He asked 
whether Canada could share any experience as to why the effort had not fructified. 
23. The representative of Malaysia
 asked the delegation of Canada to clarify whether the fourth 
event on the timeline outlined by it, i.e.  the review  of the Apotex submission, referred to the review 
of the safety and efficacy of the drug and, if so, wh ether Apotex had generated its own clinical data 
when submitting the application or whether it had re lied on the data submitted by the patent owner.   
24. The representative of Angola , speaking on behalf of the LDC Group, said that the adoption of 
the Decision of 6 December 2005 to amend the TRI PS Agreement in order to respond to difficulties 
experienced by countries with no or insufficient ma nufacturing capacity was an important milestone.  
However, five years had elapsed since this Decision had been adopted, and few Members had 
deposited instruments of acceptance of the Protocol Amending the TRIPS Agreement.  It was important to establish why countries were not comi ng forward so that collective measures could be 
taken.  The LDC Group welcomed the informal consultations undertaken by the Chairman in 
September and October 2010 to f acilitate dialogue between Members on the opportunity to hold a 
workshop on the implementation of the System.  This could help to get a sense of where impediments 
lay with regard to the acceptance process and how  the removal of such impediments could be 
facilitated including through expedite d acceptance of the amendment by individual Members.  Issues 
related to the acceptance of the TRIPS amendment c ould also be incorporated into the national and IP/C/57 
Page 10  
 
  regional technical assistance and capacity-building ac tivities undertaken by the WTO Secretariat.  He 
noted that the list of topics circulated by the Ch airman had been prepared through the consultation 
process to facilitate the annual review under Paragraph 8 of the Decision.  The sharing of experiences 
and views on the System would enable Members to have clarity on how the System could be meaningfully used and where obstacles lay.  Informat ion on alternatives to the System would also be a 
valuable resource for the LDC Group.   
25. The representative of New Zealand
 said that his delegation's interest in this issue was largely 
systemic as it did not have significant manufactur ing capacity of either brand name or generic 
pharmaceuticals.  He strongly supported the princi ples that underpinned the Declaration on the TRIPS 
Agreement and Public Health.  He noted that Ca nada had emphasized that the system was demand-
driven and that one year had passed between the au thorization by Health Canada and the request by 
Rwanda.  He asked the delegation of Canada why th ere had been such a delay.  He wondered whether 
Health Canada had done anything to advertise th e system to potential applicants, whether any other 
requests had been received, and whether there were countries that  were excluded from eligibility 
under CAMR.  With respect to the reported thr ee applications made under India's legislation 
implementing the System that were subsequently w ithdrawn, he requested the delegation of India or 
the least developed country involved to share more details of their experience. 
26. The representative of Venezuela  asked why Canada had established CAMR.  He noted that 
the delegation of Canada had said that the System had not been created to resolve the problem of 
access to medicines in developing countries.  He said that, in his view, access to medicines had 
become worse with the promulgation of the TRIPS Agreement.  He asked th e delegation of Canada 
what the intention of the General Council had then been in adopting the System. 
27. The representative of Egypt  supported the review of the Decisi on, as well as the proposal by a 
number of delegations to hold a dedicated workshop in order to facilitate the discussion of the issues 
arising under the System, including the lack of its use and the limited acceptance of the Protocol.  The participation of relevant stakehol ders could help to achieve this goal.  When the African Group had 
brought the critical issue of access to medicines to the Council for TRIPS in 2001, this had been an 
attempt to target an important public health problem.  Over the years since then, Members had engaged in laborious work  on consulting and discussing draft lan guage as a way out of this critical 
public health crisis.  When the Decision had been r eached in 2003,  his delegation had hoped that this 
problem had been resolved.  It had notified its acceptance of the Protocol Amending the TRIPS Agreement in 2008, in the belief that it was expedien t to do so to provide room for a solution to the 
urgent public health needs and that Egypt would be  able to provide urgently needed medicines to 
countries in need.  His delegation had anticipated  itself as both potential beneficiary and supplier 
under the System.  However, the System had not been as helpful as hoped in addressing this critical public health problem.  The fact that it had onl y been used once raised questions as to its 
effectiveness, let alone expeditiousness.  Likewise,  the frail drive to accept the amendment Protocol 
was incomprehensible in its own right.  The admini strative and regulatory complexity of the system, 
the lack of appreciation of business methods in s upplying markets and associat ed overhead costs, as 
well as constraining requirements, would merit further discussion. 
28. Canada's experience as one of the two Memb ers having used the System was important in 
shedding light on the issues.  The representative of Egypt put a number of questions to the delegation 
of Canada.  Firstly, in the light of its own experi ence, did Canada consider the System to be an 
expeditious solution?  Secondly, as part of CAMR's reform process, was the possibility of issuing one 
compulsory licence for several countries in order to  avoid duplication and time lags considered?  
Thirdly, could the delega tion of Canada share any information on the experience of Apotex in seeking 
a voluntary licence prior to applying for a compulsory licence?  Fourthly, to what extent had the anti-
diversion measures been onerous on Apotex?  He note d that paragraph 7 of the Decision stated that 
"Members recognize the desirability of promoting the transfer of technology and capacity building in  IP/C/57 
 Page 11 
 
 
  the pharmaceutical sector in order to overcome the problem identified in paragraph 6 of the 
Declaration.  To this end, eligible importing Me mbers and exporting Members are encouraged to use 
the system set out in this Decision in a way which would promote this objective..."  He asked to what 
extent CAMR was promoting the objective of transf er of technology as enshrined in paragraph 7 of 
the Decision.   
29. The representative of Brazil  noted that, according to the delegation of Canada, Apotex had 
decided to produce the antiretroviral Apo-TriAvir be fore there had been a request from any country.  
Even when Rwanda had identified itself as a poten tial importer, Apotex still had to go through the 
process of government procurement with other comp anies.  She asked what the economic incentives 
had been for Apotex to engage in this process and why it had not attempted to repeat this experience 
with other countries.   
30. The representative of Argentina  supported the holding of an  open-ended workshop or any 
other initiative with the objective of evaluating the functioning of the System.   
31. The representative of Switzerland  considered that the attempt by the MSF to procure generic 
medicines from Apotex was an important case, and said that it would be useful to know why the 
attempt had failed.  The information available see med to indicate that price had been the issue 
between MSF and the potential generic manufacturer .  In his view, the price offered by generic 
manufacturers could not be influenced by the Syst em itself.  The challenge was to find the most 
competitive and thus most affordable price under such  a scheme.  He asked the delegation of India to 
provide more detailed informati on regarding the precise nature of the problem between MSF and 
Apotex and wondered if the delega tion of Canada also had additiona l information on this particular 
case. 
32. The representative of Indonesia  noted that the delegation of Canada had presented the use of 
the System as effective.  However,  the use of th e System had only been able to help 21,000 patients 
in Rwanda.  He inquired whether the number of pa tients in need of HIV/AIDS treatment had been 
increasing at that time and what would have happened if Rwanda had wished to import a greater 
amount of Apo-TriAvir, i.e.  whet her it would have had to start the process again from scratch.  The 
utilization of the System was not as easy and expe ditious as his delegation had thought.  He asked 
what the situation would be if, due to a miscalculation, further disasters or other reasons, there were a call for more medicines after the licence had been issued.  Starting from scratch would require more time and would not fulfil the intention of the Sy stem, which was designed to be an expeditious 
solution to public health concerns.   
33. He quoted a September 2008 statement by Mr. Jack Kay, Apotex President and CEO, who 
had said that, "if other critical medicines are to go to Africa in a reasonable timeframe, the Federal 
Government must change the CAMR legislation.  CAMR is unworkable as it now stands."  This was a 
signal that CAMR might need to be improved in order to e xpeditiously serve public health needs.  His 
delegation commended the reform process in Canada.  However, a complete review or an overhaul of 
the System should be considered too, if necessary. 
34. The representative of Malaysia
 asked the delegation of Canada how the royalties had been set 
for the compulsory licence under CAMR, and how that amount had been calculated.  He asked whether the methodology used in determining the am ount was different from that  used in the case of 
standard compulsory licences. 
35. The representative of the European Union
 welcomed the full day of discussions, based on 
experiences and facts rather than on alleged obstacl es, and which would enable Members to evaluate 
the operation of the System.  He requested the dele gation of India to provide more information about 
the three applications to which it had referred.  He agreed with the delegation of New Zealand that the IP/C/57 
Page 12  
 
  conclusions drawn by India with resp ect to the withdrawal of these a pplications were not obvious.  He 
asked the delegation of Canada whether it ha d reviewed CAMR since the Apotex case.   
36. The representative of Zimbabwe
 noted that the delegation of Canada had said that it had only 
taken 15 days for the compulsory licence to be granted by the Commissioner of Patents under CAMR and that the system was very efficient.  However,   the domestic process in Canada was not the only 
issue to be considered, given that the System involved various players including small countries, big 
countries, big and  small industries.  For a system  to be efficient and suitable and user-friendly for 
even the smallest players, Members n eeded to look at the bigger picture. 
37. The representative of India
 said that, in September 2007, three applications for compulsory 
licences had been received by the Indian compan y Natco for export to Nepal.  Detailed discussions 
between officials at the Indian patent office, Na tco and Nepalese authorities had taken place.  He 
agreed with the delegation of Switzerland that pr icing was not covered by the System.  He said, 
however, that, pricing had not been the issue in the MSF case which had tilted the balance in favour of 
the Indian generic companies. 
38. The representative of Canada  invited potential importing countries to share specific examples 
of obstacles or concerns with respect to the use of  the System.  With respect  to the question by the 
delegation of India concerning the MSF's request fo r Apo-TriAvir in 2004, he noted that CAMR was 
a demand-driven process.  CAMR would be trigge red when the importing country as well as the drug 
and quantities needed had been identified.  In th e case involving the MSF, these specific elements had 
not been provided, so Apotex was not in a position to request even a voluntary licence from the patent 
holders, nor to request an export authorization fro m the Commissioner of Patents.  The question by 
the delegation of India about hypo thetical future instances of use of CAMR could not be answered 
without specifics.  However, the Rwanda case ha d shown that CAMR operated efficiently and 
effectively.   
39. With respect to the process to amend CAMR, Bill C-393 was a private member's bill, 
submitted by an individual, in this case a member of Parliament, which was not sponsored by the 
Government.  As part of the ongoing discussions , the Bill was currently before a parliamentary 
committee.  The standing committee on Industry, Science and Technology was scheduled to report 
back to the House of Commons by 3 November 2010 for a third reading.  The Bill suggested a 
number of changes with respect to CAMR, in cluding the introduction of a single licence, not 
restricted in time or quantity.  It was also propo sed that the anti-diversion measures be removed.  His 
Government viewed those particular changes as inconsistent with the way that Members were 
supposed to interpret the waiver of 2003. 
40. With respect to the question from the delegation of India about Ghana's request in 2005, he 
noted that his Government had not been involved in the discussions.  It was possible that some developing countries, Ghana in particular, had cont acted a Canadian generic manufacturer to discuss 
the possibility of importing medicines from Canada.  It would be worth addressing the question to the 
delegation of Ghana, which could have some additio nal details to offer, including whether the need 
expressed by Ghana had been filled.  According to hi s information, an Indian generic firm had been 
able to satisfy the request.  He invited the de legations of Ghana or India to confirm this.
 
41. Regarding Schedule 1 of CAMR, th is was intended to be a flexib le list of pre-approved drugs 
for export that remained current with the needs of developing countries and LDCs.  Schedule 1 had 
been modified twice since CAMR had been implem ented, to add a fixed dose combination HIV/AIDS 
therapy and a drug for the treatment of influenza in the case of a pandemic, i.e. Tamiflu.  The 
Canadian Patent Act had also provided for the cr eation of an advisory committee prior to May 2008, 
composed of experts from various health disciplines, to facilitate future amendm ents to Schedule 1.    IP/C/57 
 Page 13 
 
 
  42. With respect to the additional elements cont ained in CAMR, the representative of Canada 
noted that these were related to the interpretation of  the waiver.  In his delegation's view, the waiver 
required a number of conditions to be met:  namely , that the importing country was required to notify 
the WTO of its intent to use the Decision, the licensee was required to request a voluntary licence 
from the patentee prior to seeking an export author ization under the Decision;  the quantity produced 
under a compulsory licence could not exceed the amount notified;  adequate remuneration was 
required to be paid to the patentee, products shi pped, under the agreement should not be diverted to 
other markets, products were required to be sp ecifically marked and labelled, the licensees were 
required to post on a website the quantities and feat ures of the product being shipped and the intention 
was to support humanitarian policy objectives, not commercial ones.   
43. In response to the question from the delegation of Ma laysia, he said that clinical test data had 
been provided or generated by Apotex itsel f by way of proof of bio-equivalence. 
44. He noted that the delegation of New Zealand had highlighted the fact that CAMR was a 
demand-driven process.  The time in between the safety and efficacy review of Health Canada and the start of voluntary licence negotiations could be explai ned by the fact that there had been no specific 
demand made by a country, thus preventing the process  from moving to the next level.  In response to 
the second question by the delegation of New Zeala nd, he said that no additional requests had been 
received by the Government of Canada either prior to or subsequent to Rwanda's request.  He could 
not provide any definitive information with resp ect to discussions that may have occurred between 
Apotex or other Canadian generic manufacturers and countries and/or NGOs.  With respect to the 
eligibility of countries as potential importing Memb ers, he answered that CAMR went beyond the 
Decision in that it did not have any restrictions with respect to non-WTO Members.  Restrictions 
would only apply to countries which had voluntarily opted out of the system.   
45. With respect to the question from the delegati on of the United States as to what had been 
done to publicize CAMR, he said that, since CAMR  had received royal assent in 2004, government 
officials had made numerous efforts to raise the profile of CAMR both nationally and internationally 
to promote uptake of the regime by generic manufacturers.  These efforts were aimed at both eligible 
importing countries and their party purchasers such as NGOs.  In July 2006, these efforts had been 
reinforced with the launch of a government  website (www.camr-rcam.gc.ca) which served as a 
manual for interested parties.   
46. In turn, he asked what potential importing count ries had done to publicize the System within 
their own countries, specifically through discussions be tween trade and/or patent officials and health 
officials, whether at a national level or sub-national level. 
47. With respect to the question from the delegati on of Venezuela as to why CAMR had been 
established, he answered that his delegation had felt that it was in a position to make a contribution to 
access to essential medicines in times of public h ealth emergencies, it had a manufacturing capacity, 
and it had the political will to undertake the necessary domestic legislative chang es to ensure that this 
happened. 
48. In response to the questions asked by the de legation of Egypt, he said that his delegation 
considered the System to be expeditious.  In resp ect of the experience of Apotex, he noted that his 
Government had not been a party to those discuss ions.  The CAMR process had only been activated 
when Rwanda had come forward as a potential impor ting country in July 2007.  The three brand-name 
companies concerned had either entered into voluntar y licence discussions, or had confirmed that they 
would not contest the issuance of an export authoriz ation within two to three weeks of having been 
approached by Apotex.  Apotex had subseque ntly applied for an export authorization on 
4 September 2007, which was granted two weeks later.   While he could not fully answer the question 
with respect to anti-diversion measures, he did not think that a globally competitive pharmaceutical IP/C/57 
Page 14  
 
  company like Apotex had encountered difficulties sa tisfying the very limited anti-diversion measures 
that were set out in CAMR. 
49. The representative of Canada took up the qu estions asked by the delegation of Brazil 
regarding the government procurement process in Rw anda, in particular whether the export of the 
pharmaceutical product concerned had been of any ec onomic interest to Apotex and whether other 
brand-name companies had competed with Apotex.  He noted that, besides the participation of some 
Indian generic companies, he had no detailed info rmation regarding any other companies that had 
participated in the Rwanda tendering process.  This question could only be fully answered by 
Rwanda.  Apotex had won the supply contract in Ma y 2008, about eight months after the process had 
been launched.  Price had been a key factor.  When creating Apo-TriAvir, Apotex  had indicated that it 
would manufacture and sell a useful made-in-Canada  AIDS treatment without profit at its production 
cost of USD 0.39 per tablet.  Apotex had said pub licly that this price would be competitive with 
Indian products.  However, from 2006 to 2008, Apotex had not been able to sell at that price due to competition from Indian companies who had been selli ng their own version of TriAvir.  Rwanda had 
at least four alternatives from Indian generic supp liers which had been in a position to offer a lower 
price than the one which had been offered throug h CAMR, which would have made the use of CAMR 
unnecessary.  In 2008, as part of this Rwanda te ndering process, Apotex had, however, reduced its 
price by half to USD 0.195 per tablet.  Since Apotex  had publicly noted that the price of USD 0.39 per 
tablet would have enabled it to break even, it coul d be assumed that the sale at the lower price of 
USD 0.195 implied a loss in this transaction.  By accepting Apotex's new offer, Rwanda had become 
the first user of the System. 
50. In response to the question asked by the delega tion of Indonesia, the representative of Canada 
confirmed that Rwanda would have to start the a pplication process anew if it wished to increase its 
order.  The Rwandan authorities would simply have to follow the same procedures as previously.  This process would only take a matter of months, or  less compared to the initial case.  It would also 
depend on the Rwandan government procurement process.  With respect to the quote from the CEO of 
Apotex, he said that CAMR did function and was therefore workable.   
51. With respect to the question asked by Malaysia about royalties, he said that the royalty rates 
ranged between 0.02 and 3.5 per cent.   Under CAMR, the remuneration to be paid by the licensee to 
the patentee was calculated by multiplying the mone tary value of the supply contract by an amount 
that fluctuated on the basis of the importing count ry's standing on the UN Human Development Index.  
According to this formula, the lowest country on th e index would pay a royalty of approximately 0.02 
per cent, and the highest country of 3.5 per cent.  Where patentees disagreed with the royalty fixed on 
the basis of this formula, it was possible to appl y to the federal court for an order setting a higher 
amount.  This had not been the case as regards Rwanda , where the patent holders had entirely waived 
the royalty fee. 
52. With respect to the question from the delegation of the European Union as to whether Canada 
had reviewed its regime, the representative of Canada explained that a statutory review was 
incorporated into CAMR.  As one of the first c ountries to implement the Decision, Canada had found 
itself addressing many key legal and policy issues regarding the Decision for the first time.  The review had sought to ensure that CAMR was meeti ng its humanitarian objectives to make it easier for 
poorer countries to obtain cheaper generic versions  of patented medicines without derogating from 
international trade obligations or  undermining the intellectual prope rty rights necessary for continuing 
innovation in Canada.  It had provi ded an opportunity to compare Canada's legislation with that of 
other jurisdictions which had implemented the Deci sion in the meantime.  Information on the review 
along with numerous other documents, including a discussion paper and submissions from interested 
parties, were available on the dedi cated website (www.camr-rcam.gc.ca).  IP/C/57 
 Page 15 
 
 
  53. The representative of Canada agreed with the de legation of Zimbabwe about the need to look 
at the bigger picture. 
54. He asked the delegation of India whether it ha d any information about a possible partnership 
between Apotex and the Indian company Ranbaxy La boratories to export to Liberia the same fixed-
dose combination that had been sent to Rwanda a year  earlier.  He was interested to learn whether a 
voluntary licence had been secured in this case and wh ether any shipment had taken place.  He further 
asked whether there were other partnerships betw een Indian generic pharmaceutical firms and other 
foreign firms under which essential medicines were expor ted to developing countries, based on either 
voluntary or compulsory licences. 
55. The representative of India  thought that Canada had raised a very important point about 
partnerships between Indian generic pharmaceutical  firms and other foreign firms to provide essential 
medicines to developing countries.  Information regarding the partnershi p between Apotex and 
Ranbaxy Laboratories would be provided at the next  TRIPS Council meeting.  He noted that the 
question raised by the delegation of Canada had al so underscored the importance of participation of 
relevant pharmaceutical companies in TRIPS Council  discussions.  This strengthened his delegation's 
call for a dedicated workshop on the System whic h would also include relevant pharmaceutical 
companies and civil society organizations.   
56. The representative of Venezuela  reiterated his question to the delegation of Canada on what, 
in its view, the intention of the General Council had been in adopting the System.   
57. In response, the representative of Canada  said that, in his view, WTO Members had been 
looking to provide another option for developing countries, in particular  LDCs, to access essential 
medicines by allowing those with manufacturing capacity to export such medicin es in an efficient and 
effective manner.  This objective had been  achieved through the TRIPS Council's work. 
58. The representative of Cuba  asked what clinical trials and other methods had been used by 
Apotex, what test data had been referred to and what kind of quality control had been applied.   
59. As regards Venezuela's intervention about th e General Council's motivation for adopting the 
Decision in 2003 and the TRIPS amendment in  2005, the representative of Switzerland  recalled that 
the mandate under paragraph 6 of the Doha Declara tion instructed the Council for TRIPS to find an 
expeditious solution to the problem of the diffi culties that WTO Members with insufficient or no 
manufacturing capacities in the pharmaceutical sector could face.  The mandate had not, and could not possibly have been, to solve the problem of afford able access to medicines for the poor in developing 
countries through such a solution, although some Memb ers seemed to expect the System to achieve 
exactly that goal and measured its success by this st andard.  By this standard, the System was deemed 
to be a failure.  In Doha, Ministers had mandate d the TRIPS Council to find a solution which would 
allow WTO Members without manufacturing capacity in the pharmaceutical sector to make effective 
use of compulsory licensing as provided for in Artic le 31 TRIPS.  This had been achieved through the 
System, as had been evidenced by its use for exports from Canada to Rwanda.   
60. The representative of Brazil
 noted that it was very important to know that there had been no 
royalties paid and that Apotex had most probably lost money when it had to reduce its price to 
USD 0.195 to compete with Indian generic companies.  This would raise the question of whether the System was economically viable and if there would be  other examples of its use.  With the end of the 
transition period for the implementation of the TR IPS Agreement in 2005 in developing countries 
except LDCs, affordable generic medicines from s uppliers such as India would become more and 
more scarce.  This was particularly important for medicines to treat HI V/AIDS, namely second and 
third line treatments.  In 2008, the report by the Swedish National Board of Trade on "The WTO 
Decision on Compulsory Licensing" had stated that "HIV is a highly changeable virus and patients IP/C/57 
Page 16  
 
  need to switch and update their medicines regularly .  Some types of AIDS medicines were launched 
before the TRIPS rules on patent protection for me dicines were introduced in developing countries, 
and they could therefore be freely copied and sold  in these countries.  This has resulted in vigorous 
price competition for many of the older medicines u sed as the standard 'first line' treatment, even 
though most of them are still patented in high income  countries.  With many suppliers to choose from, 
there has been no need to use the Decision for these medicines." The report had also explained that 
"the situation in regards to competition and pri ce is different for the second or third line AIDS 
medicines, i.e.  medicines that patients will need wh en they have developed resistance to the first line 
medicines.  The same holds for new, more effectiv e substitutes for first line medicines.  All of these 
are patented in many countries and the prices are much higher than for older medicines.  This is 
becoming a grave concern for the countries and inte rnational agencies that offer treatment.  Patients 
need to switch to the second line medicines within a couple of years after starting treatment and these 
medicines may cost up to 12 times as much."  
61. Therefore, the discussions at this meeting would have a fundamental impact on access to 
affordable medicines in the near future.  Effo rts in the TRIPS Council and in other fora should 
concentrate on analyzing whether the economic and political incentives provided by the System were 
adequate to secure investment in the production of generic medicines at affordable prices to markets 
with no manufacturing capacity.  TRIPS-plus provisions  that adversely affected the right to access to 
medicines, such as data exclusivity of clinical tr ials, should also be analyzed.  Given that economies 
of scale were an essential element in incentives for i nvestment in this area, it was also important to 
design ways to improve the utility of the system to serve small markets. 
62. The representative of Venezuela
 said that his delegation saw the background to the System in 
a different way to Switzerland.  Before looking in to the intention of establishing the System, the 
importance of the Doha Declaration in 2001 for deve loping countries had to be recalled.  The System 
launched pursuant to paragr aph 6 of the Declaration was the only escape valve to protect public health 
in developing countries.  From 2001 onwards, prices of medicines had increased.  Before the TRIPS 
Agreement, there had been no issue with respect to th e patenting of medicines.  Despite the fact that 
Canada considered this mechanism to be successful, he believed that it had been a serious failure.  He 
therefore supported the organization of a workshop so  that delegates could discuss in an informed 
manner, taking into account the experience of  the pharmaceutical industries and NGOs. 
63. Noting that the delegation of Canada had stat ed that implementing anti-diversion measures 
had not been onerous on Apotex given that it was a well-established global company with presence in 
a number of jurisdictions, the representative of Egypt  said that while this might be the case for a 
Canadian company, it would not necessarily apply to generic companies from other countries.  While generic companies in his country would be able to  produce certain products, they might not have the 
same global reach or presence in various markets, so the anti-diversion measures could be perceived 
as onerous by them.  In his view, there was no leve l playing field with regard to such measures.  
Given that a number of questions had been raised in this discussion that would necessitate replies 
from the stakeholders, he reiterated his support for the convening of a workshop that would take on 
board comments and replies from all these stakeholders. 
64. With respect to the purpose of the System, he considered it to be part of a constellation of 
measures that had been adopted in the Doha Declarati on, in particular addressed in its first and second 
paragraphs.  He stressed the need for the WTO Agr eement and the TRIPS Agreement to be part of the 
wider national and international action to address the i ssue of the gravity of public health concerns.  
He saw the Doha Declaration as part of a constellation of measures to ensure that the TRIPS Agreement played its part and was not an obstructio n to addressing the issue of access to medicines.  
Its Paragraph 6 dealt with an extremely important element of that, addressing the difficulties of Members that had limited or no pharmaceutical manufacturing capacity.    IP/C/57 
 Page 17 
 
 
  65. While the generic pharmaceutical industry was present in his country, there had been three 
instances in the past decad e when it would not have been able  to supply needed medicines in 
sufficient quantities.  These case s included anthrax, the H5N1 avian flu pandemic and finally the 
H1N1 virus.  He thought that this situation was sh ared by the vast majority of Members.  An agile, 
dynamic and expeditious solution was therefore needed .  The fact that the System had only been used 
once over the past decade and that it had taken many years to provide a measure of workability 
indicated that it was by no means an expeditious solu tion.  This did not forebode well for the future. 
66. The representative of India  referred to the statement by the delegation of Venezuela regarding 
the purpose of the System.  Two valid points had been made with respect to the role of the System in 
access to medicines and regarding the fact that TRI PS was perceived by several developing countries 
as a problem in the context of public health.  This  was also reflected in the report of the UN Special 
Rapporteur on the right of everyone to the enjoymen t of the highest attainable standard of health 
which had been accepted by the United Nations  Human Rights Council in 2009.  The report had 
further mentioned that TRIPS-plus was aggravati ng the problem of access to medicines and public 
health.  In his delegation's view, the Swiss reading of  the System was very narrow.  Paragraph 4 of the 
Doha Declaration clearly said that "we affirm that  the Agreement can and should be interpreted and 
implemented in a manner supportive of WTO Member s' right to protect public health and, in 
particular, to promote access to medicines for all."  The Doha Declaration was significant, since it was a political assertion signifying that public health concerns overrode intellectual property rights. 
67. The representative of Canada
 expanded upon the discussion on anti-diversion measures.  
According to the System, products manufactured under a compulsory licence should be physically 
distinguishable from the patented product and, in addition, the licensee was required to post 
information on a website describing the distinguishin g features, as well as information regarding the 
quantities being shipped to each des tination.  CAMR required physical markings as part of the anti-
diversion measures.  Products exported under the licen ce had to bear the mark "XCL" for solid oral 
dosage forms, and had otherwise to be of a col our significantly different from the version sold 
domestically or had to include certain informa tion on all labelling to distinguish them from the 
domestic version.  Instead of putting its company name on the pill, Apotex had apposed the mark "XCL", and had chosen to make the colour of the pill white, instead of blue.   
68. Products were also issued an export tracking number by Health Cana da, which was required 
to be printed on the product label.  Since products had to have a product labe l, Apotex had put this 
additional information there.  Before exporting a pharmaceutical product under CAMR, the licensee 
was also required to establish a website disclosi ng the name of the licensed product, distinguishing 
characteristics, the identity of the importing country and the amount to be manufactured and sold for 
export, as well as the information identifying every known party that would be handling the product while it was in transit from Canada to the impor ting country.  Large companies were capable of 
providing or creating a website, as it was not a very onerous demand.  To further promote 
transparency, the licensee was also required to provi de to the patentee, the importing country and the 
purchaser, within 15 days of the product being exported, a note specifying the quantity to be exported and the identity of every known party that would be handling the product while in transit.   
69. In his delegation's view, paragraph 2 of the D oha Declaration was very important.  In this 
paragraph, Ministers had stressed "the need for the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights to be part of the wi der national and internati onal action to address these 
problems."  Since 2003, there had been a concerte d effort amongst WTO Members to take national 
and international action to address these problems of which the System was just one tool in a growing 
arsenal of tools.  This was a very positive developm ent and reflected a change in the environment that 
needed to be taken into account as this important issue was discussed.   IP/C/57 
Page 18  
 
  70. As regards questions relating to safety and efficacy, Canada had taken an early policy 
decision that drugs exported under CAMR should meet  the same standards for safety, efficacy and 
quality as any drug sold on the domestic market.  Health  Canada would, in any event, be in charge of 
undertaking a review, once the patents had expired,  to enable off-patent drugs to come to the 
Canadian market.  It was therefore in its best interest to  ensure that there was no double standard.  In 
the case of Apo-TriAvir, Apotex had submitted a re quest for approval of a generic drug, based on the 
three reference products that it had been using.  Safety and efficacy had been established on the basis 
of bioequivalence, as for any other generic product.  The quality of the drug had been established on the basis of a chemistry manufacturing review, which was also applied to drugs for the domestic market, as well as good manufacturing practices which were a worldwide recognized quality standard.  
The clinical trials to establish bioequivalence of the generic drug and the reference product had been 
undertaken in Canada under Health Cana da's authorization for clinical tria ls.  Such clinical trials came 
under the Food and Drugs Act and had to be approved  by Health Canada, as in any other country.  
That process had provided the information that ha d been requested for the establishment of safety, 
efficacy and quality. 
71. The representative of New Zealand
 noted that there had been a lot of discussion about the 
Canada-Rwanda case which showed that the System  could work.  There had been little discussion, 
however, about instances where the System had been considered but not used.  It was necessary to 
examine those situations at least as closely as the Canada-Rwanda case had been examined.  He 
requested more information from the delegation of India as to the three cases it had mentioned where 
applications under the System had been initiated but ha d later been discontinued.  He wished to better 
understand the facts on the basis of which the delegati on of India had drawn its conclusions.  He also 
requested more information from the delegation of  Egypt as to why it would be easier for generic 
producers in Canada to comply with the requireme nts of the System than for generic producers in 
Egypt.   
72. Furthermore, he echoed the request made by th e delegation of Canada to hear from potential 
importers.  As it was the TRIPS Counc il that was responsible for the review of the System, he felt that 
it was ultimately the responsibility of the Memb ers to communicate and understand the facts.  
Consequently, he requested to hear more from Me mbers who had considered using the System, but 
had subsequently not done so.   
73. The representative of Malaysia  asked the delegation of Canada whether there was any bar 
under Canadian law which prevented a manufacturer from applying for marketing approval of a drug 
before the expiry of the patent for the drug.  If th ere was such a bar, he asked whether there was an 
exception applying in cases where the System would be used. 
74. The representative of Indonesia  commented on a number of constraints on the System's 
implementation.  Firstly, there was resistance fro m patent holders.  Secondly, for medicines that 
needed specific technologies, developing and l east developed Members would face problems or 
would even find it impossible to manufacture those me dicines.  There was therefore a need to look 
also at Article 7 of the TRIPS Agreement with respect to the objectives of the Agreement which 
included transfer of technology.  This was one  of the solutions to address problems currently 
encountered with the System, because it was nec essary to reduce the number of countries who were 
on the demand side and sought to become manufacturi ng countries in the future.  Thirdly, he shared 
the concerns raised by the delegation of Brazi l with respect to TRIPS-plus provisions which 
represented one of the constraints in implementing the System.  Fourthly, donations from international 
funding organizations and NGOs, such as the World Bank, UNICEF, the MSF and  the Global Fund, 
generally required that manufacturers needed to  be pre-qualified under the WHO pre-qualification 
system.  Pre-qualification involved the national regulatory authority, as well as the respect of pharmaceutical industry requirements which were not easy to fulfil.  For developing Members, and 
least developed Members particularly, pre-qualification requirements were even more difficult to  IP/C/57 
 Page 19 
 
 
  implement.  Therefore, improving their capacity as exporting countries or manufacturing countries 
was similarly much more difficult.  He thought th at holding a dedicated workshop on this issue was 
necessary and very timely. 
75. The representative of India  noted that his delegation could not provide a complete timeline of 
events regarding the instances where applications to  use the System had been submitted and had later 
been aborted, as only one step had been taken.  First-hand information on this case could best be 
provided by the delegation of Nepal.  He end eavoured to gather more information from NATCO 
Pharma, the company which had applied for the com pulsory licences, to share with Members at the 
next TRIPS Council meeting.   
76. The representative of Canada  asked the delegation of Indonesia for specific examples in terms 
of resistance encountered from patent holders, and asked whether this was in relation to a potential 
use of the System.  He also asked which medici nes Indonesia had found difficult to obtain, what 
efforts it had made to try to obtain them, whethe r the System was entertained as an option to obtain 
those essential medicines and, if not, why this had not been done.   
77. With respect to Malaysia's question regarding th e ability for a generic drug to be marketed in 
Canada, the representative of Health Canada said that  the Patent Act had an early working clause that 
allowed the development of a generic drug in ad vance of the patent expiry for the purpose of 
preparing a submission seeking market authorization.  Health Canada would complete the review, but 
the market authorization would not be granted until su ch time as all issues related to the protection of 
patents were addressed.  For this reason, Apo-TriA vir could not come to the Canadian market until 
the patents concerned expired, which explained why Apotex had sought a compulsory licence to 
export Apo-TriAvir.  As regards the comments on the national drug regulatory authorities, their 
involvement was useful because they played a role  in access to medicines.  Based on the review by 
Health Canada, Apo-TriAvir had been included on the WHO's list of pre-qualified drugs by using the 
alternative procedure available to the European Union, the US Food and Drug Administration and to 
Canada. 
78. The representative of the European Union  noted that the System addressed only a specific 
aspect of the broader issue of access to medicines in the developing world.  But this was a mechanism 
that contributed to improving access to medicines.  Th e approach to this System should be voluntary 
as Members had to make it work.  Other aspects had to be taken into account with regard to access to 
medicines, such as financing of medicine purch ases, the setting-up and financing of health-care 
systems, the financing of research targeting negl ected diseases and the development of appropriate 
pricing and reimbursement policies.  These issues went well beyond intellect ual property and patent 
protection.  They exceeded the Council's mandate and were well  addressed by other organizations, 
such as the WHO, in other fora. 
79. In response to questions from the delegations of Malaysia and Indonesia regarding marketing 
authorization, the representative of the United States  referred to a policy initiative, which had been 
launched by the US Food and Drug Administration (FDA) in May 2004 to help ensure that those 
being served by the President's Emergency Plan for AIDS Relief (PEPFAR) would receive safe, effective and quality manufactured antiretroviral drug s.  This initiative included an expedited review 
process.  Through guidance and an active outreach programme to the pharmaceutical industry, FDA 
actively encouraged any sponsors worldwide to s ubmit US marketing applications for single entity, 
fixed-dose combination, and co-packaged versions of previously approved antiretroviral therapies, 
even if there was still patent or exclusive marke ting protection for the product in the United States.  
Drug products used in PEPFAR received a "tentati ve approval" where the manufacturing of these 
products met all the FDA's manufacturing quality, clinical safety, and efficacy requirements as 
required for domestic marketing purposes.  After approval or tentative approval from the FDA under 
the expedited process, a generic antiretroviral would quickly pass onto the WHO's pre-qualification IP/C/57 
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  list, because of a confidentiality agreement that allo wed FDA to share its review data with the WHO 
secretariat in Geneva.  This was relevant to the implementation of the System, because this relied not 
only on what Canada had described as its implem enting legislation, but also on other related 
measures. 
2. Implementation of the System into dom estic legislative and regulatory framework 
80. The Chairman
 said that under this topic the intention was to focus on the experience of those 
Members who had implemented the System as pot ential exporting and/or importing Members.  In 
order to have a full understanding of the situation, Me mbers had indicated that it would also be useful 
to get some feedback from those Members that had not yet implemented the System, particularly with respect to any problems they had encountered in its implementation. 
81. The representative of Canada
 said that CAMR was the Canadian legislation that implemented 
the humanitarian objectives of the Decision, bala ncing often competing policy objectives.  The 
following conditions applied under the Decision:  th e importing country had to notify the WTO of its 
intent to use the Decision;  the licensee had to request voluntary licence(s) from the patentee(s) prior 
to seeking a compulsory licence under the Decision;  the quantity produced under compulsory licence 
could not exceed the amount notified by the importing country;  adequate remune ration had to be paid 
to the patentee(s);  products shipped under the Agreem ent should not be diverted to other markets;  
products had to be specially marked and labelled;   licensees had to post on a website the quantities 
and features of the product being shipped;  and, lastly, the intention was to support humanitarian 
policy objectives, not commercial ones. 
82. During the development of legislation in 2003 and 2004, and again during the statutorily 
mandated review of  the legislation in 2006, key stakeholders, including from the R&D industry, the 
generic industry and civil society, had been consulted.  All stakeholders had supported the establishment of CAMR and continued to support it , but diverged on certain aspects of the regime.  
For example, brand name companies wanted st rong anti-diversion measures, generic companies 
sought streamlined processes with incentives to par ticipate, and NGOs wanted a liberal regime with 
no restrictions on eligible importing countries or products.  CAMR's overridi ng key challenge was to 
ensure a delicate balance between facilitating access  to medicines while ensuring that incentives for 
the innovation of new medicines and technologies remained.  CAMR pursued several objectives, 
including to:  (i) facilitate access to lower-cos t pharmaceutical products in countries facing public 
health problems;  (ii) respect Canada's obligatio ns under TRIPS and other international treaties;  
(iii) respect the domestic patent system;  and (iv)  encourage generic companies to participate in 
CAMR.   
83. CAMR's key features concerned eligible importi ng Members, eligible medicines for export, 
requirements regarding safety and quality of pr oducts, steps required to be taken by a local 
manufacturer seeking to export under CAMR, distingui shing features of products, royalties, dispute 
settlement and statutory review.  Eligible importi ng countries were listed under Schedules 2, 3 and 4.  
All LDCs and WTO Members were eligible to import except those that had opted out, such as his own 
country, the United States and France.  Non-WTO Memb er developing countries were also eligible to 
import pharmaceutical products under CAMR upon request.   
84. Eligible products for export were listed in Sc hedule 1.  Every product on the WHO's list of 
Essential Medicines that was patented in Canada w as eligible for export.  He noted that Schedule 1 
had been amended twice since 2005 to include new products such as the HIV/AIDS triple-
combination therapy Apo-TriAvir and Tamiflu.   CAMR ensured that a product exported under 
CAMR met the same safety, efficacy and quality standards as those products destined for the 
domestic market.    IP/C/57 
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  85. A local manufacturer who sought to export under CAMR was required to submit the 
following information to the Commissioner of Patent s:  (i) the name of the patented product for 
export, the eligible importing country, the existing pa tents and the quantity to be manufactured;  (ii) a 
certified copy of the importing country's notification to the WTO or to Canada (if the importing country was not a WTO Member);  and (iii) a declara tion that the applicant had attempted to negotiate 
a voluntary licence with the patentee(s) at least 30 days prior to submitting an application for an 
export authorization. 
86. Exported products had to carry prescribed marki ngs and labelling.  The name of the product, 
quantity, markings, and importing country had to be  disclosed on the manufacturer's website.  The 
royalties paid to the patentee(s) ranged between 0. 02 per cent and 3.5 per cent and were linked to the 
importing country's level of development as lis ted on the UN Human Development Index and the 
value of the contract.  If the licensee failed to meet the terms and conditions of the export 
authorization, or if diversion occurred, terminati on of the licence by the Federal Court was possible. 
87. Recognizing the importance and the groundbreaking nature of CAMR, its enabling legislation 
included a clause requiring the Minister of Industry to  review the relevant sections of the Patent Act 
two years after CAMR's coming into force.  In  November 2006, the Government of Canada had 
launched a 60-day consultation seeking public views and opinions on CAMR.  Through this process, 
the Government had received numerous submissions from the pharmaceutical industry, NGOs, academia, and Parliamentarians.   
88. In December 2007, the Minister of Industry had tabled a report in Parliament containing the 
results of the consultation period and review.  The report and submissions were available online at the 
CAMR website (www.camr-rcam.gc.ca).  The report on Canada's statutory review of CAMR had 
been a comprehensive analysis that considered each element of the regime in the context of relevant 
international trade rules.  It had also take n into consideration circumstances surrounding the 
Commissioner of Patents granting of an export author ization to Apotex under CAMR.  In addition, the 
report had examined the broader context of disease bu rden in the developing world, international and 
country-based initiatives to address that burden, a nd some economic consider ations affecting the 
supply of antiretroviral drugs used to treat  HIV and AIDS.  The 2007 report had found that 
insufficient evidence had accumulate d since the coming into force of CAMR to warrant legislative 
changes at that juncture. 
89. However, the report had also highlighted ot her systemic factors outside the operational 
aspects of CAMR that appeared to be discouraging its  use.  These factors included a lack of eligible 
importing Member notifications to the WTO or to  Canada and a lack of awareness of CAMR among 
eligible importers.  In response to the second fact or, Canada had varied a nd intensified its outreach 
activities to continue to raise awareness of CAMR among eligible importers, pharmaceutical 
regulatory authorities and generic manufacturers.  Mere  months before the report had been released, 
Apotex had applied for and received an author ization to manufacture and export under CAMR in 
order to fulfil the need identified by Rwanda in its  WTO notification.  The report had been released 
well before Apotex had shipped Apo-TriAvir to Rwanda in September 2008.   The report had taken 
note of this and had provided the following assessment:  "...  for the moment at least, the granting of 
the first and only export licence under the waiver to Apotex, and the circumstances surrounding it, 
suggest that CAMR works reasonably well and quick ly, provided an importing country has made a 
requisite notification to the WTO".  With no further notifications to the WTO since the report's release 
in 2007, this observation remained valid. 
90.
 The representative of China  provided an overview of the domestic implementation of the 
System and the main changes relating to public health  in the amended Patent Act.  The patent law of 
the People's Republic of China had first entered in to force on 1 April 1985 and had been amended in 
1992, 2000 and 2008.  On 27 December 2008, th e Standing Committee of the National People's IP/C/57 
Page 22  
 
  Congress had adopted a decision to revise the patent la w.  The new patent law had come into effect on 
1 October 2009.  Subsequently, the State Counc il had promulgated its decision on revising the 
implementing regulations of the patent law in January 2010.  They had come into force on 
1 February 2010, concluding th e third revision process.   
91. The 2003 Decision and the Protocol Amending the TRIPS Agreement provided a means to 
assist Members who had insufficient or no manufactur ing capacities in the pharm aceutical sector to 
address public health problems.  WTO Members could grant a compulsory licence to manufacture and export patented pharmaceuticals to such Members.  China had accepted the Protocol in October 2007.  
To implement it, Article 50 had been added to the Chinese Patent Law, enabling the State Intellectual 
Property Office (SIPO) to grant compulsory licences to manufacture patented pharmaceuticals for the 
purpose of exporting to eligible Members.  Article  50 provided that, for the purposes of public health, 
the patent administration department and the State Council could grant a compulsory licence to manufacture a patent-protected pharmaceutical product for export to countries or regions specified in the relevant international treaties to which China wa s a party.  In Article 53, the requirement that 
compulsory licensing should be used predominan tly for the supply of the domestic market was 
waived with respect to the export of a patented medicine for the benefit of public health.  The 
amendment of Article 57 clarified that royalties had to  be paid to the patentee according to relevant 
provisions in the Decision and the Protocol when a compulsory licence was granted for public health 
purposes.  The implementing regulations provided further details, such as the definition of a 
pharmaceutical product in Rule 73, paragraph 2.  Ru le 74, paragraph 4, provided that the grant of 
compulsory licences pursuant to Article 50 of the Pate nt Act had to be in accordance with the relevant 
international treaties to which China was a party.  The amendments to the Chinese patent system had 
fully implemented the System into the domestic law.   As of 1 October 2010, no compulsory licence 
had been granted by the Chinese authorities.  SIPO was planning to revise the procedures relating to 
compulsory licensing to provide specific requirements in line with the Protocol. 
92. The representative of the European Union
 said that his delegation had implemented the 
System as a potential exporting Member.  On 17 May 2006, it had adopted new legislation to that 
effect.  Regulation (EC) No. 816/2006 of the Euro pean Parliament and of the Council represented an 
instrument that allowed the compulsory licensing pr ocedure under the System to fit within the context 
of EU member States' national patent laws and th e respective compulsory licensing procedures.  This 
gave transparency and clarity for those companie s operating within the EU internal market and 
wishing to apply for compulsory licences for export to countries in need.  It created a legal basis at the 
EU level to enable European generic producers to  manufacture medicines under compulsory licences  
for export to countries in need.  It did not impose further restrictions on the Decision. 
93. The scope was one of the main elements of this regulation.  Firstly, the beneficiary countries 
included both least developed countries and low-in come developing countries, including those who 
were not members of the WTO.  Secondly, there were no specific exclusions as to the scope of 
diseases.  The Regulation referred to public health  problems and did not target specific diseases.  
Thirdly, the Regulation applied to any product of  the pharmaceutical sector, including medicinal 
products, active ingredients and dia gnostic kits ex vivo.  The Regulation also foresaw a role for 
non-governmental and internationa l organizations who could become involved in any purchasing 
procedures and could also make requests on behalf of an importing country with that country's 
approval.   
94. An applicant for a compulsory licence unde r the System was required to submit its 
application to the competent authority of the EU member State where the medicine was going to be manufactured, or from where it was going to be exporte d.  The applicant was able to avail himself of 
the EU scientific opinion procedure or equivale nt national procedures to ensure the safety and 
efficacy of the medicine.  The EU had felt th is was a necessary complement to the licensing 
mechanism in order to assist importing countries.  Th e application had to contain information as to the  IP/C/57 
 Page 23 
 
 
  name and contact details of the applicant, the non-proprietary name of the product concerned, the 
amount of medicine to be produced and the name  of the importing country or countries.  The 
competent authority would grant the compulsory licen ce and determine the remuneration to be paid to 
the patent holder.  In the case of an urgency, the remuneration was a maximum of 4 per cent of the 
total price to be paid by the importing country.  In  other cases, the remuneration had to be adequate. 
95. The licence had to be non-exclusive, non-assignabl e and limited in scope and duration.  The 
products had to be clearly identified.  The licensee had to inform the authorities of the quantities and 
distinguishing features of the products and also keep records in order to allow verification of whether 
the terms of the licence, in particular those relati ng to the final destination of the product, had been 
met.  The scope and duration of the licence were determined by the needs stated by the importing 
country or countries.  Appeals against competent authorities' decisions and disputes relating to the 
compliance with the licence conditions were hear d by the appropriate body under the law of the 
member State concerned.  Once e xport had occurred, all parties had an interest in seeing that 
medicines were not diverted from those in need.  The Regulation prohibited re-importation into the 
European Union and provided for cu stoms authorities to take action against goods being re-imported.  
The patent holder could use existing national proc edures to enforce its rights against re-imported 
goods if they did enter the European Union.  Te rmination of the licence granted under the Regulation 
would be notified to the TRIPS Council.  No com pulsory licence had thus far been granted under the 
Regulation, but any application from developing co untries would be welcome.  Moreover, he noted 
that his delegation had committed itself not to use the System as an importer.   
96. The representative of Hong Kong, China  said that her delegation had notified its acceptance 
of the Protocol on 27 November 2007.  The Pa tent Amendment Ordinance 2007 had been passed on 
30 November 2007 and had taken effect on 22 February 2008.  It had introduced two new parts to the 
Patents Ordinance, one dealing with the importa tion of pharmaceutical products under the Protocol 
and the other dealing with the exportation of such pr oducts.  Prior to the Protocol coming into effect, 
the Amendment Ordinance allowed her delegation to rely on the temporary waiver to enable it to 
import patented pharmaceutical products from a WTO Me mber to address a public health crisis or to 
export such products to a WTO Member.   
97. Her delegation had declared that it would not use the System as an importer unless in a 
situation of national emergency or  other circumstances of extreme urgency, which the chief executive 
in Council may declare.  During such a declared pe riod of extreme urgency, the Director of Health 
would be empowered, if he consider ed there were insufficient or no manufacturing capacity, to grant a 
non-exclusive compulsory licence to any person to import the pharmaceutical product or to do any 
other act which would otherwise amount to an in fringement of the patents concerned, without the 
consent of the patentee.  The Director of Health w ould be required  to notify the patentee of the grant 
of the import compulsory licence as soon as was prac ticable and to publish the grant of the licence 
and its terms and conditions in the specified official journal.   
98. The Amendment Ordinance stipulated that the import compulsory licence would be subject to 
the following conditions:  (a) the entire quantit y of the pharmaceutical product imported under the 
licence should only be used domestically and not be exported to other places;  (b) the pharmaceutical 
product should be clearly identified through specifi c labelling or marking as being imported pursuant 
to such licensing system;  (c) the licence was not assignable except as part of the business of the 
assignor that enjoyed the use of the patent under th e compulsory licence;  and (d) such other terms 
and conditions as the Director of Health deemed fit, having regard  to the public health needs in 
Hong Kong, China in a declared period of extreme urge ncy.  The Director of Health had the power to 
terminate an import compulsory licence where there w as contravention of any term or condition of the 
licence.  Payment of royalties to the patent owne r was only required where he could show that 
remuneration had not been paid in the exporting juri sdiction and that all legal remedies to recover 
royalties had been exhausted.  The amount of rem uneration should be agreed between the Director of IP/C/57 
Page 24  
 
  Health and the patentee.  Where an agreement could not be reached, the amount of remuneration 
could be determined by the court.  The Amendm ent Ordinance provided for the disposal of any 
remaining stocks upon the termination of the period of extreme urgency.  The licensee was required to 
take reasonable steps to recall such stocks and eith er surrender them to the government or to the Hong 
Kong Special Administrative Region or dispose of them in such a way as may be agreed with the 
patentee. 
99. The Amendment Ordinance also empowered the Di rector of Health to grant a compulsory 
licence for the making and export of a pharmaceutical product to be supplied to a WTO Member recognized as a least developed country or a WTO Member that had given notice to the TRIPS Council that it intended to import pharmaceutical products under the System.  Where the importing 
WTO Member did not declare a national emergency or  other circumstances of extreme urgency, the 
applicant for an export compulsory licence was re quired to make reasonable efforts to obtain an 
authorization from the patentee on reasonable comme rcial terms and conditions  before applying for 
the licence.  The grant of the export compulsory  licence was subject to the terms and conditions 
stipulated in the Amendment Ordinance, including  as regards (a) the quantity of the pharmaceutical 
products that could be produced and sold for export; (b) the need to clearly identify the 
pharmaceutical products through specific labelling or  marking as being produced pursuant to such 
licensing system;  (c) the posting on a dedicated webs ite of information relating to the amount of the 
pharmaceutical product that would be exported to th e importing Member and the labelling or marking 
used to identify the product;  and (d) such othe r terms and conditions as the Director of Health 
deemed fit.  The Director of Health had the pow er to terminate an export compulsory licence where 
there was non-compliance with any term or condition of the licence or where any information, 
documents or evidence specified in or accompanyi ng the application for the compulsory licence was 
false, incorrect or incomplete.  The remunerati on payable by the licensee of an export compulsory 
licence was to be determined by the Director of Health on a case-by-case basis. 
100. The representative of India
 said that his delegation had implemented the System in its patent 
legislation in the form of Section 92A of the Indian Patent Amendment Act 2005.  Under 
Section 92A, a compulsory licence would be available for manufacture and export of patented pharmaceutical products to any country having in sufficient or no manufacturing capacity in the 
pharmaceutical sector for the concerned product to  address public health issues, provided the 
compulsory licence had been granted by such a country, or the country had by notification or otherwise allowed importation of th e patented pharmaceutical products from India.  Use of Section  
92A was not restricted to WTO Members and was simp le to use.  The guiding principle for India had 
been to make the use of the System as easy as po ssible.  India had accepted the Protocol Amending 
the TRIPS Agreement on 26 March 2007. 
101. The representative of Korea
 said that his delegation had accep ted the Protocol Amending the 
TRIPS Agreement on 24 January 2007.  At the time of the adoption of the Protocol, his delegation 
had declared that it would not use the System as an importer.  In 2005, Article 107(1)(v) of the Patent 
Act and other relevant provisions had been en acted, and the Regulation on Expropriation and 
Licensing of Patents had been amended to provi de statutory grounds and to set procedures for 
granting a compulsory licence for export.  In July 2010, the Regulation had be en further amended to 
make the procedures easier and more transparent.   
102. To obtain a compulsory licence under domestic pate nt law, an applicant had to make a request 
for the grant of a compulsory licence.  This app lication had to include the method for calculating 
remuneration, the reason for the request and supporti ng evidence, and evidence of failed negotiations 
with the right holder.  In the case of a compulsory licence for export, the applicant additionally had to 
attach:  (i) proof that the compulsory licence re quest was for the purpose of treating a disease that 
threatened public health in the importing country;  (ii) confirmation of the intent of the importing 
country;  (iii) an evaluation of the economic va lue of the pharmaceutical product in the importing  IP/C/57 
 Page 25 
 
 
  country;  and (iv) proof that the importing country had notified the WTO of the name and quantity of 
the pharmaceutical product and its lack of manufacturing capacity.  In the case of non-WTO Member LDCs, the applicant additionally had to provide proof that the importing country had notified the 
Government of Korea of the name and quantity of  the pharmaceutical product and the country's lack 
of manufacturing capacity.  In addition, the appli cant had to submit the dis tinguishing features that 
differentiated the product manufactured for export under the compulsory licence from products 
manufactured by the patentee or other interested part ies, as well as the internet address where such 
details would be made available. 
103. Copies of the request for a compulsory licence had to be delivered by the Commissioner of 
Patents to the patent right holder and other interest ed parties in order to provide an opportunity to 
submit comments.  The Commissioner also had to pu blish the request for the compulsory licence in 
the patent gazette and proceed to a preliminary regi stration of the terms of adjudication.  If necessary 
to decide on the grant of the compulsory licen ce, the Commissioner could seek assistance from the 
Intellectual Property Dispute Mediation Counc il which was composed of representatives from 
different ministries and other expert bodies.  The Commissioner had to determine in writing the scope 
and duration of the compulsory licence, the amount of remuneration, the method of payment, as well 
as other terms of implementation.  The adjudication ha d to be made within six months of the request.  
In case of compulsory licensing for export, the licence had to be granted if all the legal requirements were satisfied.  This feature differentiated su ch licences from procedures applying to standard 
compulsory licences.  Following the grant of the licence,  a copy of the decision had to be delivered to 
the patentee and other interested parties, an abstr act of the decision had to be published in the patent 
gazette, and the non-exclusive licence be registered.  Remuneration had to be pa id or a bond be posted 
as a security by the licensee.   
104. Amendments had been made to the Regulation on Expropriation and Licensing of Patents in 
July 2010 to make procedures for export com pulsory licences easier, more transparent and 
predictable.  To achieve this objective, among othe rs, any competent Minister seeking the grant of a 
compulsory licence could also request that a search be  carried out regarding the patents related to the 
invention for which a compulsory licence was requested.  An additional provision also provided detailed criteria for calculating the amount of re muneration to be paid to the patentee.   
105. The representative of Switzerland
 said that Switzerland was a WTO Member which had 
manufacturing capacity in the pharmaceutical se ctor.  The Swiss pharmaceutical industry had 
particular expertise and strength in the area of re search and development of innovative medicines and 
also was active in the generic medicines sector.  His delegation had fully opted out of the System as 
an importing country in 2003.  It had implemented th e System in its national legislation as a potential 
exporting country and had been the second WTO Memb er to notify its acceptance of the Protocol 
Amending the TRIPS Agreement (WT/Let/547) on 13 September 2006.  The Bill implementing the 
System had met the approval of the various stakehol ders, including all relevant Government agencies, 
political parties, NGOs, industry associations and consumer organizations.  The relevant report 
summarizing the consultations that had taken place could be accessed on the Swiss Government homepage (http://www.admin.ch/ch/d/gg/pc/doc uments/1167/Ergebnisse_d.pdf).  The Swiss 
Parliament had accepted the amended Patent Act, which included the implementation of the System, 
on 22 June 2007.  The Act had entered into for ce on 1 July 2008 and had been notified to the WTO 
(IP/N/1/CHE/P/9).   
106. The revised Patent Act contained a new Article  40(d), which provided for the possibility of 
applying for a compulsory licence for export purposes.  The pre-existing and, in the revision, renumbered Article 40(e) contained general provisions on uses without  authorization of the patent 
right holder.  It had been revised to incorporat e additional and specific terms and conditions for a 
Paragraph 6-type compulsory licence.  The Patent  Ordinance, which served as an executive regulation 
complementing the Patent Act, provided in its Artic le 111 further terms and c onditions to be respected IP/C/57 
Page 26  
 
  in the grant of such an export co mpulsory licence.  In addition to the legal provisions in the Patent Act 
and in the Ordinance, further helpful information and policy guidance on the contents of the amended 
law as well as the legislator's intention and interp retation of the relevant legal provisions could be 
found in a so-called legislative dispatch, which was a sort of explanatory report by the Government 
which had been sent together with the proposed Bill to the Parliament.  The substance of the Swiss 
legislation implementing the System was thus clo sely following the provisions and requirements as 
contained in the Protocol.  Those were mirrored in  a clear and straightforward manner in the amended 
Swiss Patent Act. 
107. Under the Swiss implementing legislation, com pulsory licences could be issued for specific 
medicines, active ingredients, diagnostic kits or vaccines patented or manufactured under a patented 
process.  Any country that met the terms and c onditions established by the System could be an 
importing country under Swiss law.  Exclusions a pplied to WTO Members in accordance with their 
full or partial opt-out status.  A country did not need to be a WTO Member in order to be a beneficiary country.  Responsible for the grant of the compulsory licence were the courts responsible 
for patent matters to which an a pplication had to be submitted.  As  part of the application, the 
applicant had to submit the notifications require d under the System.  The court had to treat the 
application expeditiously.  It was re quired to submit the details of the licence, if granted, to the Swiss 
Intellectual Property Office which would notify them  to the WTO.  As in the case of standard 
compulsory licences, adequate remuneration was to be determined on a case-by-case basis by the 
Court.  However, the Government's explanatory re port had specified that the economic value of the 
patent's legal use under a compulsory licence in the beneficiary country had to be taken into account, 
as well as the country's level of development, based on its position on the UN Human Development 
Index.  The owner of a Paragraph 6 compulsory licence had to obtain authorization from the Swiss 
Agency for Therapeutic Products to manufacture und er the Federal Drug Law.  The standards of good 
manufacturing contained in that Law also had to be  complied with.  Sanctions and criminal penalties 
would apply if the terms and conditions of th e licence were not complied with, including anti-
diversion measures.  In case of a failure of comp liance with the terms and conditions, the Court could 
also revoke the licence.  His delegation had not en countered any particular problems in implementing 
the System, which provided sufficient guidance.   
108. His delegation did not consider the System or  its domestic implementation, whether as an 
importing or exporting country, to be a panacea for affordable access to medicines in developing countries.  Rather, it was one contribution that the TRIPS Council had been able to make to combat 
challenges posed to public health.  His delegation had no practical experience using the System, as to 
date it had not received any request for a compulsory licence thereunder.   
109. The representative of Croatia
 said that Croatia had implemen ted provisions pertaining to the 
grant of compulsory licences, supplementary certif icates and prohibition of re-importation into its 
Patent Act in 2007, which was reflected in the Act on Amending the Patent Act of December 2009.  
Croatian authorities had begun the process of accepti ng the Protocol Amending the TRIPS Agreement 
in May 2010.  Acceptance of the Protocol had b een passed in Parliament and the process would be 
completed and the outcome be published in the offici al journal in due course.  The instrument of 
acceptance would soon be notified to the WTO.   
110. The representative of Ecuador  noted that, under the Ecuadorean Constitution, the State had to 
guarantee the health of the Ecuadorian people and to facilitate the availability and accessibility of high 
quality, safe and effective medicines.  The Constituti on further provided that public health interests 
prevailed over economic and commercia l interests (Articles 3 and 32).  It also provided that health 
was a human right.  It was therefore not just a political commitment to promote and secure health, but a constitutional right to which every Ecuadorian citiz en was entitled.  This implied an obligation for 
the State to secure the enjoyment of the highest pos sible standard of health care and the establishment 
of a health protection system which guaranteed equal health opportunities for all citizens.    IP/C/57 
 Page 27 
 
 
  111. He said that Ecuador had adopted a common i ndustrial property regime with other Members 
of the Andean Community, through Decision No.  486 of September 2000.  This legislation, which was part of Ecuador's domestic law and had direct  legal effect, had enabled all Andean Community 
member countries to entertain compulsory licensing re quests and, where appropriate, to grant them as 
provided for by Articles 61 to 66 of Decision No.  4 86.  Moreover, Ecuador's Industrial Property Law 
of May 1998 had established compulsory licensing regulations at the domestic level as per its 
Articles 154 to 156.  These regulations were to be  interpreted in conjun ction with the Andean 
Community regulations.  Other components of the legal framework for compulsory licensing were Article 31 TRIPS and the Doha Declaration on the TR IPS Agreement and Public Health.  All of these 
elements provided the legal basis for authorizing co mpulsory licensing for reasons of public interest, 
emergency or national security in Ecuador. 
112. The Government's domestic policy guaranteed universal access to medicines for Ecuadorian 
people, through the provision of safe and reliable generic medicines under compulsory licence.  This health policy was the result of the implementati on of the national development plans 2007-2009 and 
2010-2013.  To grant a compulsory licence for reas ons of public interest, emergency, or national 
security, the law required the President to first make a declaration of a state of emergency or other 
extreme urgency.  Once that had been done, Ecua dor's Intellectual Property Authority (IEPI) was 
authorized to initiate the necessary procedures to cons ider the request and, if relevant, the granting of 
compulsory licences.  For example, on 14 April 2010, IEPI had granted a compulsory licence for Ritonavir, a first-generation drug for the treatment  of HIV/AIDS.  He noted that this compulsory 
licensing process had taken six months, as opposed to  three years in the case of export under the 
System from Canada to Rwanda. 
113. He said that the fundamental problem in the use of Article 31 of the TRIPS Agreement was 
that compulsory licensing under this provision did not cover all public health needs since it did not provide for situations where a country had no cap acity, or limited capacity, to produce pharmaceutical 
products.  To address the territorial restrictions in Article 31(f), the System had been adopted.  
However, whereas it had been intended to provide a viable and expeditious solution to address public 
health problems of countries with limited or no production capacity in the pharmaceutical sector, it had only resulted in limited access to generic versions  of last generation essential medicines, such as 
those needed to treat HIV/AIDS.  As regards the compulsory licence granted for the generic medicine 
Ritonavir, it was patent-protected in Ecuador, but  not in the manufacturing country, which had made 
it possible to export it to Ecuador under the standard rules of Article 31 of the Agreement. 
114. Instead of meeting the objective of expeditiously  satisfying the urgent public health needs of 
developing countries, the implementation of the Sy stem would, on the contrary, establish burdensome 
and excessive processes, conditions and limitations  for those countries that had no or limited 
production capacities, as in the case of Ecuador, th ereby further complicating the already demanding 
conditions imposed by Article 31 and hampering access to imported generic versions of essential 
medicines.  Those considerations explained why his delegation was reluctant to ratify the Protocol and 
to make the System a permanent part of the Agreement. 
115. The representative of Japan
 said that his delegation had notified its acceptance of the Protocol 
Amending the TRIPS Agreement in August 2007.  He  elaborated on the related domestic rules for 
administering the System as a potential exporting Member.  The "Guideline for Administering Award System" was binding on administrative authorities and provided for a comprehensive compulsory 
licensing scheme in accordance with international oblig ations which applied to his delegation.  Under 
this guideline, compulsory licences for the purpose of  the System could be granted in accordance with 
the provisions of the TRIPS Agreement, the Decision and the Protocol Amending the TRIPS Agreement.  Compulsory licences for the purpose of  the System could be requested under Article 93 
of the Japanese Patent Act, which allowed for an  "award granting non-exclusive licence for public 
interest".  IP/C/57 
Page 28  
 
  116. To accept the Protocol, the approval of th e House of Representatives, the House of 
Councillors and the National Diet of Japan had been  needed.  In the proceedings of the Diet, the 
question had been posed as to what acceptance of the Protocol would mean, taking account of the fact that pharmaceutical companies already exported pharma ceutical products to LDCs  at affordable prices 
and that, although being the main  potential beneficiary, no LDC had accepted the Protocol at that 
point.  The System was nevertheless considered im portant to increase the options available to LDCs 
in the case of a national emergency.  Acceptance of  the Protocol was important to facilitate the 
entering into force of the TRIPS Amendment.   
117. He said that, in this context, his delegation would appreciate receiving further information on 
the state of play from LDCs who had not yet accepted the Protocol as potential importing Members. 
118. The representative of Chile
 noted that the incentives provided to Members to implement the 
System could be usefully looked at.  Such incen tives seemed to be largely for countries that had 
capacity to produce generic medicines.  A large nu mber of developing countries had a well-developed 
pharmaceutical sector with manufacturing capacity.  However, it was unlikely that these developing 
countries would be called upon to manufacture drugs  under the System, as importing countries would 
prefer to rely on exporting countries where safet y and efficacy of the pharmaceutical products was 
assured.  He wondered about incentives to accept th e Protocol for a Member who would not use the 
System as an importing country, and was unlikely to use it as an exporting country.  It was therefore important to look at the incentives provided to count ries to accept the Protocol and to implement the 
System, in order to enable a broader discussion of why only a limited number of Members had 
accepted the Protocol.   
119. The representative of Canada
 said that one benefit of the System was that royalties to the 
patent holder would have to be paid in the e xporting country.  He noted that some WTO Members 
who wished to import under the System might, ne vertheless, still be required under their domestic 
legislation to pay a royalty when a compulsory licence was issued, unless they had made the appropriate changes to their domes tic legislation to take full advantage of the System.  He asked 
whether any potential importing countries had ha d any experiences in that regard.   
120. The representative of Nigeria
 asked whether there had been any efforts made by governments 
or generic companies to transfer technology to l east developed countries.  He also asked whether 
potential exporting Members, other than Canada  and the European Union who had specifically 
addressed this point, had safeguards in place to ensu re the safety and efficacy of drugs produced under 
the System.   
3. Process of acceptance 
121. A representative of the Secretariat  briefed the Council on the procedural requirements of 
acceptance and current status of acceptances of the am endment to the TRIPS Agreement.  He recalled 
that the TRIPS Amendment was a formal amendm ent to an international treaty, the TRIPS 
Agreement.  The amendment process had started with the adoption, on 6 December 2005, of the 
General Council decision on the Amendment of the TR IPS Agreement.  This decision reflected the 
political consensus reached by all WTO Members to amend the Agreemen t.  In terms of international 
treaty law, it was the Protocol attached to th e General Council decision that amended the TRIPS 
Agreement.  However, for the amendment to have  legal effect in the WTO, Members needed to 
formally express their consent to be bound by th e Protocol.  The General Council decision and the 
Protocol explicitly invited Members to accept the Protocol.  The WTO Agreement, to which the 
TRIPS Agreement was attached as Annex 1C, included special rules on amendments in its Article X.  
Under Article X:7 of the WTO Agreement, formal  acceptance of the TRIPS Amendment occurred by 
Members depositing an instrument of acceptance with the Director-General, who served as the depositary of the multi- and plurilateral trade agreements.  IP/C/57 
 Page 29 
 
 
  122. He said that there were several requirements for depositing a valid instrument of acceptance.  
First, the instrument of acceptance had to be a written document.  He noted that there was no 
established form for this document, and that each  Member would have its own practice in accepting 
international treaties and treaty amendments.  Howeve r,  under international law, the instrument of 
acceptance had to have certain elements in orde r to give clear and unambiguous expression to the 
relevant Member's intention and consent to be bo und by the relevant instrument, in this case, the 
Protocol.  In particular, the instrument of acceptance had to:  (i) reproduce or at least clearly identify the Protocol by its title and by the place and date  of its adoption, for ex ample, "the Protocol 
Amending the TRIPS Agreement, done at Geneva on 6 December 2005";  (ii) indicate that the Member concerned formally accepted the Protocol;  (i ii) indicate the date and the place of issuance of 
the instrument of acceptance;  and (iv) be issued by one of the "the Big Three", namely the head of 
state, the head of government, or the foreign mi nister of the Member concerned, depending on the 
Member's constitution and practice.  Alternatively, the instrument of acceptance could be issued by 
another person, provided that one of the Big Three had formally issued what was known in treaty law 
as "full powers", which was a document specifically authorizing this person to accept the Protocol on 
behalf of the Member concerned.  In any event, the instrument of acceptance had to be signed and had 
to indicate the name and title of the person signing the instrument. 
123. He noted that the instrument needed to be  deposited within the period of acceptance.  
Following two extensions of the original accep tance period, the current deadline for depositing 
acceptances was 31 December 2011.  In other words, a Member had until this date to provide its 
signed instrument of acceptance to the Director-General. 
124. On the question of the current status of accepta nces, the representative of the Secretariat said 
that, as the General Council Decision and the Protocol pr ovided, the Protocol was due to take effect in 
accordance with Article X:3 of the WTO Agreement.  Pursuant to Article X:3, the amendment to the 
TRIPS Agreement resulting from the Protocol "shall ta ke effect for the Members that have accepted 
[it] upon acceptance by two thirds of the Memb ers and thereafter for each other Member upon 
acceptance by it".  He noted that two thirds of the Me mbership would need to deposit an instrument of 
acceptance for the Protocol Amending the TRIPS Agreemen t to enter into force;  this had not, as yet, 
occurred. 
125. He said that there was a need to clearly dis tinguish between acceptance of the Protocol and 
implementation of the Paragraph 6 System in Member s' domestic legal framework.  He noted that it 
had been brought to the attention of the Secret ariat that certain Members had postponed the 
acceptance of the Protocol because they had linke d it to the adoption of domestic implementing 
legislation.  Acceptance of the Protocol was an  international treaty law act expressing a Member's 
consent to be bound by the Protocol on the internatio nal plane.  It represented a Member's consent that 
WTO Members were entitled, i.e.  permitted but not re quired, to use the system incorporated in the 
TRIPS Agreement through the Amendment.  This pro cess of acceptance needed to follow the relevant 
Member's constitutional requirements and the international treaty law requirements.   
126. He noted that the act of ac ceptance was not dependent upon do mestic implementation of the 
Protocol.  The international act of accepting the Protocol needed to be clearly distinguished from the domestic  implementation of the Pa ragraph 6 System.  WTO Members could choose to take advantage 
of the flexibility provided in the Protocol and, if they did so, there could be a need to put it in place through a domestic legislative and regulatory pr ocess as governed by each Member's domestic 
procedures.  Legally speaking, those two processes were therefore entirely separate.  Members could 
choose to deal with them either jointly or separat ely.  For example, a Member could choose to deposit 
an instrument of acceptance for the Protocol with out adopting domestic legislation implementing the 
Paragraph 6 System, because the Member was onl y committing itself to accept that additional 
flexibilities became an integral part of the TRI PS Agreement.  Similarly, a Member could put IP/C/57 
Page 30  
 
  implementing legislation into place without having accepted the Protocol.  There were examples for 
both approaches. 
127. The representative of the Secretariat noted that the purpose of his presentation was to 
facilitate Members' understanding of the procedural implications of accepting the Protocol Amending 
the TRIPS Agreement.  To further assist Members in  drawing up their instruments, the information he 
had provided together with a model instrument of acceptance would be made available in writing.  If 
particular Members had queries on how to accept the TRIPS Amendment, they could contact the 
Legal Affairs Division of the WTO Secretariat to seek further information. 
128. The Chairman
 emphasized the importance of the final point made by the representative of the 
Secretariat, namely that it was not necessary for a Member to have taken any decision whether and, if 
so, how to implement the TRIPS Amendment at th e time when it would deposit its instrument of 
acceptance.  In essence, the accepta nce only expressed the willingness of the Member to be bound to 
accept that other Members were entitled to use the m echanism.  It was his understanding that some 
Members had postponed acceptance of the amendment because they had linked it to domestic implementing legislation.  While there could be dom estic reasons to do so, it was not necessary for the 
purposes of acceptance. 
129. The representative of Argentina
 informed the Council that the draft law for the approval of 
the Protocol Amending the TRIPS Agreement had passed  the first steps in the relevant procedures of 
the Senate.  In the chamber of deputies, the Commi ssions of Foreign Affairs, Religious Affairs and 
Industry had expressed a favourable opinion.  On 28 September 2010, the draft law had been included 
on the agenda for the plenary meeting. 
130.  The representative of the United States  said that his delegation would find the circulation of 
draft templates for acceptance of the Protocol an d related legal materials to be a very helpful 
contribution to the Council's work .  His delegation had been the first Member to notify its acceptance 
of the Amendment, and looked forward for other Members to follow as expeditiously as possible so 
that the two thirds requirement would be met in order for the amendment to enter into force.   
131. The representative of India  said that the presentation by the Secretariat had made it clear that 
the acceptance of the protocol and the implementing legislation were two different, not sequential, 
procedures.  He asked whether this distinction w as reflected in the technical assistance activities of 
the Secretariat and whether the Secretariat was planning to circulate a list of Members who had adopted implementing legislation? 
132. Another representative of the Secretariat
 responded that, with respect to the first question by 
the delegation of India, a distinction was made in  technical assistance activities of the Secretariat 
between the use of the system and its implemen tation, including through domestic law, and the 
separate procedure of preparing and submitting a fo rmal acceptance of the Protocol Amending the 
TRIPS Agreement.  Technical assistance was a major priority for the Secretariat.  It was constantly 
evolving depending on demand.   
133. With respect to the second question, he noted th at the Secretariat had an informal list of 
Members that had adopted implementing legislation, based on the notifications to the Council.  The 
Secretariat had not analyzed the laws and regula tions notified by Members in detail.  Informal 
materials had been compiled which provide a ge neral overview of choices made by Members to 
implement the System.   
134. The representative of Brazil  noted that her delegation was interested in receiving this informal 
compilation of countries that had implemented domestic  legislation and asked if the Secretariat could 
provide it informally.  IP/C/57 
 Page 31 
 
 
  135. The representative of India  said that his delegation was also interested in receiving a copy of 
the informal compilation of countries who had implementing legislation in place. 
136. The representative of the Secretariat  noted that there was a formal list of countries with 
implementing legislation, which was contained in  the draft report to the General Council on the 
annual review of the Paragraph 6 System.  While the list of formally notified legislation was therefore 
on the record of the Council, the informal material to which he had referred was merely a summary of 
the details of such legislation. 
4. Capacity building on the Paragraph 6 System and related TRIPS flexibilities 
137. The Chairman  noted that the Council had held the a nnual review of technical cooperation and 
capacity building on the previous day.  He recalled that, on the previous day, the Council had held its 
annual review of technical cooperati on and capacity building.  He drew  attention to the written reports 
that the Secretariats of the WTO, UNCTAD, WHO and WIPO had provided to the Council 
(IP/C/W/553, and IP/C/W/549 and addenda 3, 4 and 5, respectively) which also contained useful 
information relevant for the discussion of this topic.   
138. The representative of the Secretariat  provided an overview of the technical cooperation 
undertaken by the WTO Secretariat in relation to  public health and access to medicines, with a 
particular focus on the System, supplementi ng the more comprehensive report on technical 
cooperation that had been provided the previous day under agenda item K (IP/C/W/553).  Public 
health and the TRIPS provisions most directly relevant to innovation and access to medicines had 
formed an integral part of technical assistance activ ities undertaken by the Secret ariat in relation to the 
TRIPS Agreement.  In general, technical coope ration activities relating to TRIPS were directed 
towards assisting Members to understand the rights and obligations, including  the available options, 
which flowed from the TRIPS Agreement and re levant decisions of WTO bodies and dispute 
settlement jurisprudence.  This covered TRIPS fl exibilities and policy options under TRIPS, including 
the System, and the interplay between TRIPS sta ndards and policy choices.  Technical cooperation 
activities had also developed an increasing practic al focus, so that presentations and descriptive 
materials were supplemented by practical ex ercises and simulations, and dialogue between 
participants.   
139. Since the adoption of the TRIPS waiver in 2003 and the TRIPS amendment in 2005, virtually 
all technical cooperation activities concerning TRIPS had addressed the System, whether they took 
the form of regional workshops, Geneva-based events , national seminars, or more tailored activities.  
He estimated that the number of relevant activities certainly exceeded one hundr ed.  Over such a wide 
range of activities, the extent to which the System  was covered, and the specific aspects which were 
explored, varied considerably, dependent on several factors, including the level of the participants, 
ranging from introductory overviews to detailed reviews of the operation of the system, and on the 
particular thrust of the programme, i.e.  whether it was, for example, a dedicated workshop on TRIPS 
and public health, or a general overview of current  TRIPS issues.  The coverage of such activities 
would typically include:  (i) the negotiating histor y and policy background of the Doha Declaration 
and the System, based on WTO documents;  (ii) th e specific scenarios in which the System was 
intended to operate;  (iii) the operational details of  the System, including the content and procedures 
for filing the required notifications;  (iv) practi cal group exercises on the use of the System;  and 
(v) the legal acceptance of the TRIPS amendment and the nature of the steps required to give effect to 
it. 
140. Strong emphasis had been laid on cooperation with  other international organizations in the 
conduct of such technical assistance.  Following th e Doha Declaration and the development of the 
System this meant, for instance, that the World He alth Organization had become a regular participant 
in virtually all regional and Ge neva-based activities, the only constraints being the inevitable IP/C/57 
Page 32  
 
  logistical ones, bringing a vital public health pers pective to each of these programmes.  The larger or 
more focussed programmes had been  enhanced further by the participation of the full spectrum of 
those concerned with access to me dicines: civil society, public sector procurement initiatives, industry 
representatives, public-private partne rships, and policy analysts.  Events, such as the Colloquium and 
Advanced Course had included presentations from pa rticipating scholars and policy analysts from a 
wide range of countries, many of whom had chosen  to address access to medicines and related issues. 
141. He highlighted the series of six workshops on the TRIPS Agreement and Public Health that 
had been convened in Ge neva.  These programmes had opened w ith expert overviews from the WHO, 
WIPO and WTO Secretariats on the interplay between  intellectual property a nd public health, and had 
included extensive material on the public health -related elements and flexibilities in the TRIPS 
Agreement.  They had dealt with the wider contex t of public health and intellectual property and the 
full range of relevant TRIPS standards, policy optio ns and flexibilities.  They  had naturally covered 
extensively the implementation and application of the System, including through case studies.  These 
workshops had drawn on experts with a wide ra nge of experiences and backgrounds to provide 
sessions on a range of key issues in the interplay between public health and intellectual property, 
including regulatory approval and quality control of medicines, the role of competition rules, 
procurement policy and strategies for essential medici nes, and the use of patent landscaping to guide 
policymakers.  The workshops had emphasized di alogue and diverse perspectives.  Recent sessions 
had concluded with a wide-ranging panel discussi on on the relationship between TRIPS, innovation 
and public health.  This discussion had provided an opportunity for representatives of the research and 
generic industries, access to medicines progra mmes, not-for-profit product development, and 
innovation and production capacity programmes for deve loping countries to share their views and for 
participants to engage actively with them.  Substa ntive contributions had been made by the WHO and 
WIPO, and presentations by speakers with different backgrounds (including a range of Geneva-based 
missions, NGOs and academia), so as to afford a co mprehensive overview of the key players' views 
and the most important aspects related to public health.  These workshops had also aimed to bring 
together participants (not only speakers) with di fferent backgrounds (from the areas of health policy, 
intellectual property and trade) so that they coul d learn from each other and to promote understanding 
that interdepartmental cooperation was beneficial on the domestic front just as it was internationally. 
142. The increased focus on technical cooperation relating to public health and intellectual 
property had been assisted through active dialogue, coordination and partnership with the WHO and 
WIPO.  This very productive cooperation had fac ilitated further involvement of WHO and WIPO 
experts in WTO technical cooperation activities, whic h had enabled more effective and more tailored 
technical cooperation from a richer and more well  informed factual background.  This cooperation 
had also led to joint technical cooperation ac tivities, including a technical symposium jointly 
organized by the three secretariats on "Access to Me dicines: Pricing and Procurement Practices" in 
Geneva on 16 July 2010.  The purpose of the sympos ium had been to gather experiences in the pricing 
and procurement of medicines as important determinants of access and to examine how and where to 
obtain information on access to medicines, their pri ces and their availability.  It had provided an 
opportunity for participants with different backgr ounds, coming from governments, international and 
philanthropic initiatives on the procurement of medici nes, civil society organizations and industry, to 
share experiences, take stock of the presen t situation and examine future needs. 
143. Three future directions might be considered w ith respect to the technical cooperation work of 
the WTO Secretariat.  First, the increasing trend towards partnership with other organizations, both 
within the established trilateral part nership, and beyond it, would be highly desirable, at the level of 
planning, coordination and programme delivery, so as to ensure the necessary breadth of expertise 
was available and to leverage the investment of resources more effectively.  Second, a practical 
understanding of the relevant elemen ts of the TRIPS Agreement and the System in particular might be 
embedded in a practical way into operational procurement programmes,  with greater interconnection 
between the technical cooperation activities and t hose who undertook procurement of medicines, for  IP/C/57 
 Page 33 
 
 
  instance to facilitate the communication of demand for medicines through the System.  Third, the 
enhanced and more integrated information base that  was gradually emerging concerning, for example, 
patent coverage, prices and access to medicines by  vulnerable populations, would enable technical 
cooperation to be more focussed, tailored and practi cally oriented towards specific drug procurement 
objectives. 
144. The representative of UNCTAD  noted that his organization's initial mandate on issues related 
to access to medicines had come from the Commission on Investment in 2005.  The 2005 Commission had requested UNCTAD to initiate work  on local production of pharmaceuticals in 
developing countries, with particular reference to the role that IP and technology transfer might play.  
That mandate had been taken up later at the Ac cra Accord, by which UNCTAD had been given a 
broader mandate to work on the development dimens ions of intellectual property.  The Accra Accord 
mandate, which governed UNCTAD's activities directly , had also mentioned the WIPO Development 
Agenda and had called upon UNCTAD to  cooperate with WIPO on issu es related to the development 
dimension of intellectual property.  Finally, UNCTA D had been named as a stakeholder in the WHO 
Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, in 
particular for issues related to technology tran sfer, intellectual property and local production of 
pharmaceuticals.  UNCTAD defined intellectual propert y broadly, looking at where to draw the line 
between the grant of exclusive rights and what should  be in the public domain, and not just covering 
the exclusive rights themselves.  Intellectual propert y formed part of larger development concerns 
including health, education, i ndustrial development, technology transfer, innovation, agricultural 
development and various other areas of development.  There was a need to ensu re that the intellectual 
property system functioned to support important development objectives.  Intellectual property was 
therefore not an objective in its own right, but rather  a means to an end.  In the context of flexibilities 
for public health, the strategic use of flexibilities ba lanced with obligations under international treaties 
could help to ensure better alignment of intell ectual property policies with development objectives. 
145. UNCTAD's intellectual property advisory ser vices were based on requests from developing 
countries and LDCs.  They resulted in advisory re ports, which contained analysis, recommendations 
to the country based on research field missions and wide stakeholder consultations in the country.  These advisory reports could be either published,  such as the report on Uganda's Development 
Dimensions in IP, published in June 2010 (accessibl e at http://www.unctad.org/ddip), or they could be 
private.  The output would be given only to the requesting government Ministry.  In addition to advisory services, UNCTAD had run a series of regional workshops on TRIPS and local production 
of pharmaceuticals in developing countries.  UNC TAD had held four regional workshops, two for 
Eastern Africa, one for Southern and Western Afri ca, and one for South-East Asia.  These workshops 
had had a total of 203 participants, 33 in 2009, 52  in 2008, 74 in 2007 and 44 in 2006.  The audience 
for these workshops had been government officials, local pharmaceutical producers, health NGOs and 
academia.  In total, the beneficiaries had include d 19 countries and three regional organizations.  The 
textbook that had been used to conduct these works hops had been developed in-house and would soon 
be published in a document called the "Refer ence Guide on Intellectual Property and Local 
Production of Pharmaceuticals".  Follow up courses to these regional workshops had been organized 
by a German NGO called INVENT, with the support of a German grant. 
146. UNCTAD's technical assistance activities were backed up through an active programme of 
research and analysis.  Examples of the products of  this programme had included joint publications 
with the International Centre for Trade and Su stainable Development (ICTSD) on issue papers, a 
paper series on Technology Transfer for Successf ul Integration into the Global Economy and 
UNCTAD-ICTSD policy briefs on WIPO Development Agenda issues.  UNCTAD had considered the 
possibility of a policy brief on the IP and medici nes issue in the future.  Presently, UNCTAD was 
engaged with the WHO and the European Union in  a series of case studies on local pharmaceutical 
production and related tec hnology transfer.  All research was either commissioned or written in house 
by staff and then peer-reviewed.  UNCTAD had e ngaged in a limited amount of consensus building IP/C/57 
Page 34  
 
  activities, with respect to TRIPS and public health issues.  With respect to the WHO Global Strategy 
and Plan of Action, UNCTAD had co-hosted with UNIDO, WHO and ICTSD an ECOSOC Ministerial Breakfast Roundtable on global public health, high quality, low cost pharmaceutical 
production in developing countries.  UNCTAD had also had a few expert seminars on an ad hoc basis 
in 2006 and 2007, dealing specifically with the question of local production of pharmaceuticals. 
147. The representative of the WHO
 outlined the foundation of his organization's perspective on 
access to medicines.  The Constitutio n of WHO stated that the enjoym ent of the highest attainable 
standard of health was one of the fundamental rights of every human being.  In recent years, the scope 
and content of the right to health had been further clarified in international law.  Access to essential 
medicines today was established as a part of the right to health that obliged governments to work for 
its progressive realization and intellectual property rights were one of the many determinants for 
access to medicines.  WHO had a longstanding mandate to work at the interf ace of public health and 
intellectual property.  This had been reinforced by the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property that  had stated that "WHO shall play a strategic 
and central role in the relationship between public  health and innovation and intellectual property…" 
148. The Global Strategy had recognized the impor tance of patents as an  incentive for the 
development of new health-care products, but had co ncluded that "this incentive alone does not meet 
the need for the development of new products to  fight diseases where the potential paying market is 
small or uncertain." The Global Strategy had also affi rmed that "there is a crucial need to strengthen 
innovation capacity as well as capacity to manage  and apply intellectual property in developing 
countries, including, in particular, the use to the full of the provisions in the TRIPS Agreement and 
instruments related to that agreement, which provi de flexibilities to take measures to protect public 
health." In fulfilling this mandate, the WHO had worked continuously in collaboration with other 
relevant international organiza tions and with WHO Country and Regional Offices, to support its 
member states in their endeavours to apply and manage intellectual property in a manner that 
maximized health-related innovation, protected public  health, and promoted access to medicines for 
all.   
149. In accordance with the Global Strategy, the W HO had strengthened its efforts to coordinate 
work in the field of public health and intell ectual property with other relevant international 
organizations.  The Director-General of the WHO ha d exchanged letters with the Directors-General of 
the WIPO and the WTO to enhance collaboration a nd coordination of respective activities in this 
field.  Based on this exchange of letters the Secr etariats met every month to coordinate activities and 
to discuss possible areas of cooperation and joint wo rk around public health and intellectual property. 
150. The WHO's priorities in technical cooperation had been to provide member states with 
information, training and technical assistance on how  to apply and manage intellectual property in a 
manner that maximized health-related innovation an d promoted access to medical products.  Special 
emphasis had been given to the implementation and use of flexibilities and public policy options in 
accordance with the TRIPS Agreement and the Doha  Declaration to promote implementation of the 
TRIPS Agreement that supported access to medical pr oducts and needs-driven innovation.  Further 
details of the activities carried out since 2008 were contained in the WHO's report on its technical and 
financial cooperation activities. 
151. The representative of the UNAIDS noted that th e work of the UNAIDS and its co-sponsoring 
agencies was guided by the health-related Mille nnium Development Goals (MDGs) with special 
attention to MDG 6 which was "to halt and reverse th e spread of HIV, Malaria and other epidemics by 
2015".  With AIDS being the leading cause of death worldwide among women of reproductive age, and with the possibility of virtually eliminating mo ther-to-child transmission of HIV, an integrated 
approach to the AIDS response was centra l to improving maternal and child health.  IP/C/57 
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  152. This TRIPS Council discussion was timely for a number of reasons, not least because of the 
increasing number of people living with HIV in need of antiretroviral treatment, and concerns about 
increasing costs.  Antiretroviral treatment for HIV infection was significantly reducing mortality for people living with HIV.  At the end of 2009, 5.2 million people were on HIV treatment, a twelve-fold 
increase from 2003 when the WHO and UNAIDS had first launched the historic 3-by-5 Initiative.  
According to estimates, the number of additional pe ople for whom antiretroviral treatment would be 
needed could soon reach 15 million.  The global ec onomic crisis had begun to adversely affect 
prospective commitments to AIDS from both donors and low- and middle-income countries.  For the 
first time in a decade, disbursements from donors for HIV/AIDS actually fell in 2009 from a high of USD 7.7 billion one year earlier.  The 2009 report of the inquiry of the United Kingdom's All-Party 
Parliamentary Group on AIDS into long-term ac cess to HIV medicines had reported that "we are 
sitting on a 'treatment time bomb.'" The cost of the least expensive first generation regimen had 
dropped to less than USD 70 per patient, per y ear.  But as increasing numbers of people moved 
towards more efficacious and tolerable treatment regimens, some experts projected drug prices to double compared to first generation regimens.  As patients developed drug resistance and required 
more expensive and more highly patent-protected  second- and third-line antiretroviral medicines, 
some projections saw treatment costs escalating as much as twenty-fold.   
153. In addition to the important work being undertaken by the WHO, under the UNAIDS division 
of labour, UNDP had been given a mandate to serv e as the lead cosponsoring agency within the 
UNAIDS in providing support to governments to in corporate public health -related TRIPS flexibilities 
into domestic legislation.  In cooperation with  the WHO and on behalf of the UNAIDS, the UNDP 
had provided policy and technical support to c ountries reforming domestic intellectual property 
legislation in this area.  As part of its cap acity building activities on the System, the UNDP had 
recently provided assistance to civil society or ganizations advocating for a revised Access to 
Medicines Regime in Canada.  Canada  had been the first country to ame nd its law to give effect to the 
Decision.  Bill C-393 had been proposed to streamlin e the practicability of CAMR.  Together with the 
Canadian HIV/AIDS Legal Network, UNDP had co-org anized consultations to explore opportunities 
to strengthen the CAMR in February 2010.  The focus of the discussions had been on ensuring 
compliance of Bill C-393 with the TRIPS Agreement and on giving more flexible and rapid effect to 
the Decision.  In addition, a the UNDP staff member  had been invited by and had appeared before the 
Canadian Parliament to provide technical information. 
154. In 2003, the UNAIDS
 had welcomed the multilateral consensus among WTO Members 
regarding access to affordable medicines for count ries without sufficient manufacturing capacity in 
the pharmaceutical sector.  We had appreciated that the consensus covered other public health problems in addition to AIDS, since people living with HIV were prone to  a host of opportunistic 
infections, such as tuberculosis, cancers, funga l infections and others, and these diseases were 
important health problems in themselves.  The U NAIDS had urged that the arrangements under the 
Decision be implemented in the most flexible manner possible, so that countries could utilize the 
System easily and efficiently in their efforts to  ensure greater access to HIV medicines for their 
peoples.  In reality, very few importing countries ha d introduced provisions that would facilitate the 
System's use.  In 2007, the UNDP had provided assi stance for the introduction of such provisions to 
the legislator in Zanzibar, United Republic of Ta nzania.  The Industrial Property Act 4 of 2008 had 
come into operation in the second half of 2008  and contained a number of important TRIPS 
flexibilities, including the exclusion of pharmaceutical  patents until 2016 or such other time as might 
be agreed by WTO Members.  Similar technical assistance had been provided by the UNDP to other sub-Saharan African countries in the process of amending legislation.   
155. The UNDP had provided technical and policy support on the utilization of non-voluntary 
licences under Article 31 TRIPS.  In partnership with  the Intellectual Property Institute of Ecuador, 
UNDP had held stakeholder consultations on compulso ry licensing in Quito in March 2010.  Similar 
assistance had also been provided to the Governme nt of Thailand through a WHO mission in 2008 in IP/C/57 
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  which resource persons from the UNDP, UNCTAD and WTO had participated to provide technical 
information with regard to the TRIPS Agreemen t.  The UNDP had provided capacity development 
activities to assist States to implement their inte llectual property commitments made either through 
the process of acceding to the WTO or during negotiations on free trade agreements.  Examples of such technical co-operation had included a regiona l conference on access to essential medicines, HIV 
and intellectual property, held in  Kiev in September 2009, organized by the UNDP and the Open 
Society Institute.  The UNDP had supported capac ity development trainings for patent examiners 
focusing on the examination of pharmaceutical patents.   Those had been carried out in Africa, the 
Arab States and Latin America.  He noted that  the UNDP, WHO and UNAIDS would soon be issuing 
a joint briefing paper on the use of TRIPS fl exibilities to improve access to HIV treatment.   
156. The UNAIDS and UNDP had also provided techni cal and policy support to recipients of 
Global Fund Grants in using public  health-related TRIPS flexibilities to increase the availability of 
affordable antiretroviral medicines.  The proc urement policy of the Global Fund called for its 
beneficiaries to obtain quality medicines at the lo west possible price and encouraged grantees to 
utilize the TRIPS flexibilities to this end.  As donor s faced a period of extended financial uncertainty 
and understandably heightened their focus on accountability and value for money, the UNAIDS 
expected continuing and even heightened inter est in TRIPS flexibilities, including the System. 
157. The representative of WIPO
 said that his organization's activities comprised studies and 
documents on flexibilities and options, legislative a nd policy assistance related to patents, as well as 
national and regional seminars, me etings and workshops, which also addressed flexibilities, including 
the System.  Among the studies that WIPO had prepared as part of the first group was a document 
presented to the Committee on Development and In tellectual Property (CDIP) on patent-related 
flexibilities in the multilateral legal framework and their domestic implementation.  Another example 
was a document presented to the Standing Committee on Patents, containing an experts' study on 
exclusions from patentable subject matter and exceptions and limitations to patent rights.  Some of the 
topics covered were closely related to the TRIPS Co uncil's discussions.  He also noted the existence 
of other studies related to health.  For example,  there had been a WIPO study on patents and their 
relationship with viruses, influenza and other health  issues, that had been prepared by WIPO upon the 
request of the WHO in 2007.  There had also been a joint study by WHO and WIPO on innovation and public health.   
158. With respect to legislative assistance and pub lic policies, WIPO's work had looked at 
114 Member countries' national legislation.  In those countries, WIPO had identified 19 cases where 
the Decision had been implemented domestically.  Out of those 19 countries, one group, including 
Canada and the EU, had implemen ted the Decision with a purely exporting vision.  Another group, 
including Singapore, had implemented it with an importing country's approach.  From October 2009 
to October 2010, the WIPO Secretariat had review ed the respective draft laws of ten Member 
countries on their request, looking at the way in wh ich the rules included flexibilities, in particular 
with reference to the System.  During the same pe riod, upon request by certain member states, WIPO 
had also drafted six laws focusing exclusively on patents, including the domestic implementation or 
proposed implementation of the System.  Six expert  missions and two visits to Geneva had been 
carried out in order to discuss details relating to flexibilities, in particular the System, with the 
authorities concerned.  Among the issues that had b een studied, and the different options that had 
been explored, was the Decision and how to make fu ll use of the System even before acceptance of 
the Protocol Amending the TRIPS Agreement had take n place.  Furthermore, the waiver regarding the 
payment of remuneration in the importing country had also been considered.  Finally, WIPO had also 
provided legislative advise with respect to the id entification of enforcemen t mechanisms to ensure 
that products were not diverted from their intended markets under the System.   
159. As regards the organisation of  and participation in nationa l and regional workshops and 
meetings.  WIPO's Legislative and Policy Advise S ection, Patent and Innovation Division, had taken  IP/C/57 
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  part in 4 regional meetings and 6 regional semi nars from October 2009 to October 2010, most of 
which had been organised in cooperation with the WTO.   The topic of flexibilities, in particular the 
System, had been discussed at length.  The Secretar iat of WIPO was currently carrying out a series of 
other activities, including several colloquia on selected patent issues, such as the research exemption 
(October 2006) and flexibilities in the patent system (February 2007), as well as the Symposium on 
intellectual property (December 2008) and the conf erence on intellectual property and public policy 
issues (July 2009). 
160. Another representative of WIPO noted that  new pharmaceutical products resulted from 
innovation.  Innovation systems were increasingly global and this had profound implications for 
technology transfer, market competition, economic development and public policy.  Many policy 
debates saw science, technology and innovation as cruc ial to identify threats and find solutions.  This 
posed two main challenges: first, ensuring that  policy responses worked, and second, ensuring that 
critical innovations did not bypass the developing world.  WIPO had created the Global Challenges 
Programme to contribute to these policy debates.  The approach built upon the contribution of 
intellectual property to economic growth and societ al benefit.  The goal was to ensure that the 
mechanisms operate effectively and that the n eeds of the poor in developing countries were not 
overlooked.  Intellectual property was not seen as an end in itself but as an instrument of public 
policy, i.e.  an instrument to stimulate innovation and to support the diffusion of innovation.  This 
required transparent and effective structures, nati onal and multilateral policies, intellectual property 
management capacity, and support for licensing stru ctures that enhanced the use of intellectual 
property.  WIPO's activities focused on four areas:  (i) reinforcing interactions with WIPO's member 
states;  (ii) promoting informed policy discussions;  (iii) strengthening WIPO's networks;  and (iv) 
developing effective concepts and mechanis ms and facilitating their implementation.   
161. Cooperation and dialogue with partners from othe r international organizations, such as the 
WHO, WTO, and UNCTAD, and also with region al and national organizations, NGOs and civil 
society, the private sector and academia were importa nt aspects of WIPO's work in the area of public 
health.  WIPO had engaged actively with WHO in th e context of the adoption of the Global Strategy 
and Plan of Action on Public Health, Innovation and Intellectual Property.  It was working actively 
with WHO and WTO to identify and provide its contribution to the implementation of the Global Strategy.  To this effect the three organizations met on a regular basis to discuss and exchange on their 
relevant programme activities.  A technical Symposium on "Access to Medicines:  Pricing and 
Procurement Practices" had been jo intly organized on 16 July 2010. 
162. WIPO supported WHO's Intergovernmental Mee ting on Pandemic Influenza Preparedness:  
Sharing of Influenza Viruses and Access to Vaccines and other Benefits (IGM) with its intellectual 
property expertise.  Upon request by WHO, it ha d contributed a working paper on "Patent issues 
related to influenza viruses and thei r genes", published on WIPO's website 
(http://www.wipo.int/patentscope/en/lifesciences/ip_h ealth.html) and on the WHO Avian influenza 
website (http://www.who.int/csr/disease/avian_inf luenza/wipo_ipdoc/en/index.html).  WIPO was 
equally engaged in providing intellectual property ex pertise to the initiative of  the Special Programme 
for Research and Training in Tropical Diseases to set up an African Network for Drugs and Diagnostics Innovation, the African Union Pharmaceutical Manufacturing Plan for Africa, and the UNITAID Medicines Patent Pool Initiative. 
163. He noted that it was a particular challenge to show how intellectual property systems and 
policies could enable access to medicines.  A centra l aspect was information about (i) applicable laws, 
(ii) the existence or absence of rights and (iii)  technology.  A special focus was on information 
generated in developing countries.  Such informatio n remained difficult to obtain.  WIPO worked to 
improve capacity in national offices to administer the patent system.  Increasingly, information was 
available via the Patentscope portal (http://www.wi po.int/patentscope/en/lifesciences/ip_health.html), 
WIPO's gateway to patent information.  The challe nge was to appropriately use that information.  IP/C/57 
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  This required capacity in making the informati on available, as well as finding and analyzing the 
information.  It required capacity to proactively use the information to ge t access to technology and 
innovation.  Intellectual property was not the goal but the tool.  An intellectual property right could also be an indication for an opportunity.  WIPO remained committed to con tinue working with all 
stakeholders in the context of in tellectual property and public health. 
164. The representative of India
 asked the representative of WIPO how technical assistance had 
changed following the adoption of the development ag enda, particularly the focus on the exercise of 
TRIPS flexibilities.  With respect to the presentation by  the WHO, he noted that it had been stated that 
special emphasis had been given to the implemen tation and use of TRIPS flexibilities and public 
policy options.  However, the WHO's annual report (I P/C/W/549/Add.4) did not reflect this emphasis.  
He asked the representative of the WHO how th e WHO assessed the System and whether it had 
conducted a study as to why the System had only been used once in the past sev en years.  Noting that 
the System provided for measures to harness economi es of scale, he asked whether the WHO factored 
this into its programmes, particularly for LDCs.  Finally, he wondered how free trade agreements 
promoted by developed Members which circumsc ribed TRIPS flexibilities impinged on efforts made 
by the WHO.   
165. The representative of the European Union  acknowledged that devel oping and least developed 
countries might have faced structural challenges in  implementing the System.  In many instances, 
technical assistance and capacity building had been crucial to enab le those countries to recognize and 
act on the implications of the TRIPS Agreement on public health policies and establish workable 
laws, procedures and practices to give effect to th e Doha Declaration and the Decision.  This had 
required sound technical advice on how to best inte grate the Doha Declaration and the Decision into 
intellectual property policies and practices.  His de legation had integrated sound legislative advice and 
clarification on how to give effect to the System in order to facilitate access to medicines into its 
intellectual property technical cooperation programmes with developing countries. 
166. In response to the question from the delega tion of India, the representative of WIPO  noted 
that, within the CDIP, the Secretariat had been requested to prepare a document on patent-related 
flexibilities and legislative implementation at the nati onal and regional level.  This had been submitted 
to the previous session of the Committee.  WIPO  was currently working on forthcoming documents 
that would include all the flexibilities regarding patents and related technological fields.  WIPO 
provided information to Member countries with respec t to the implementation of  legal frameworks of 
which flexibilities within the multilateral framework we re part.  Efforts had been made to identify 
those flexibilities that would fit into the developm ent goals of each of the countries that requested 
WIPO's advice.   
167. The representative of the WHO  noted that his organization's work emphasized the use of 
TRIPS flexibilities.  The way in which member  states implemented Article 27 of the TRIPS 
Agreement, how they defined what was new, what was an inventive step and what was capable of 
industrial application, had a great impact on what c ould be patented under natio nal patent laws.  This 
provision, therefore, offered public policy options, which might  be called flexibilities under the 
TRIPS Agreement.  The WHO had not studied or commissioned a study as to why the Paragraph 6 System had only been used once.  Member states had not requested such a study, perhaps because the 
System was part of the WTO framework.   
168. He said that the needs of LDCs received par ticular attention in the WHO's work.  It had 
participated actively in the workshops on the LDCs needs assessment organized by the WTO 
Secretariat, including the recent workshop in Bangl adesh and the forthcoming workshop in Senegal 
which was directed to the needs assessment of Fr ench-speaking African LDCs.  However, the WHO 
had not received any request with regard to the implementation of the System from LDCs or other 
developing countries, nor had it received any request with respect to the regional dimension of the  IP/C/57 
 Page 39 
 
 
  System.  With regard to the bilateral free trade ag reements and their impact on the WHO's work, he 
referred to the Global Strategy, which urged governme nts to take into account, where appropriate, of 
the impact on public health when considering adopt ing or implementing more extensive intellectual 
property protection than was required by the TRIP S Agreement, without prejudice to the sovereign 
rights of member states.  The WHO gave advice and technical assistance to its member states to the 
effect that, when they entered into agreements th at went beyond the level of protection provided by 
the TRIPS Agreement, they should carry out a public  health impact assessment in order to take an 
informed decision on the agreement they  were envisaging to enter into.   
169. The representative of Brazil  noted that the TRIPS Agreement contained many more 
exceptions than those contained in its Article  27, citing a recent WIPO study on exclusions, 
exceptions and limitations to patentable subject ma tter.  Supporting India, she called for a broadening 
of the discussion.   
170. The representative of Ecuador  noted that technical cooperation programmes of international 
organizations seemed to increasingly take into acc ount flexibilities.  However, such programmes 
continued to be focused on institutions such as intell ectual property offices.  It would be beneficial to 
know whether similar technical assistance activities were  planned to broaden participation to involve 
other stakeholders and how the development dimens ion was covered with respect to the effective 
implementation and use of TRIPS flexibilities, in particular as regards compulsory licences and the System.  He asked the representative of WIPO  for more details on their projects under the 
development agenda, including relevant items rela ted to TRIPS flexibilities.  He also wondered how 
international organizations, such as the WTO and WI PO, could make better use of their resources for 
technical cooperation in collaboration with other organizations, including UNCTAD, WHO and 
UNAIDS, to implement the flexibilities.   
171. As regards the inclusion of stakeholders outside the intellectual property offices, the 
representative of WIPO said that national policy make rs were primarily in charge of legislating and 
incorporating TRIPS flexibilities into domestic law.   Beyond this initial implementation stage, there 
might well be other actors who could be involved in the intellectual property system.  With respect to 
WIPO's work in the area of flexibilities, he noted th at it provided assistance not just in implementing 
laws, but also in identifying the most appropriate public policies for a country. 
172. The representative of India
 requested the representative of the WHO to prepare a detailed 
study on TRIPS flexibilities pertaining to public h ealth in its technical cooperation activities.   
173. Supporting the statement made by the delegation of Ecuador regarding WIPO's intervention, 
the representative of Venezuela  quoted from a lecture on TRIPS flexibilities which had stated that 
"almost all the national patent regimes in developing countries were based on the European and 
American systems.  Patent rights in developing countries were often based on colonial laws or on drafts elaborated with technical assistance from WIPO and patent offices from developed countries.  Most of the technical assistance provided to deve loping countries focused more on conformity with 
the provisions of the laws relating to rights of  patent holders than on the implementation of 
flexibilities within a multilateral framework that protected public health.  The inability to access 
information about optimal practice were another problem that explained the lack of technical 
knowledge to implement TRIPS flexib ilities in national laws.  As a r esult, developing countries were 
unaware of the measures and successful strategies put in place by other developing countries to overcome problems with access to medicines.  Co nsequently, countries from the same region which 
encountered similar or identical difficulties, app lied different strategies with varying degrees of 
success.  More importantly, while the majority of  developed countries offered technical assistance and 
best practices on how to protect patent rights, no manual or technical assistance had addressed best practices with respect to compulsory licensing an d competition law, looking at, for example, the IP/C/57 
Page 40  
 
  extensive use made of it by the United States to stop the abuse of patent right s and to address other 
public interests. 
5. Any alternatives to the use of the Paragraph 6 System to achieve the objective of access 
to medicines, procurement policies, and other related aspects affecting access to medicines 
174. The representative of the Secretariat
 informed Members about its recent technical cooperation 
activities that shed light on the broader context a ffecting procurement strategies to promote effective 
access to medicines.  In July 2010, the WHO, WIPO  and WTO had jointly organized a technical-level 
symposium on access to medicines, pricing and procurement practices.  This symposium had aimed to promote understanding as to the experience of intern ational and regional agencies in the pricing and 
procurement of medicines as an important determin ant of access.  It had provided an opportunity to 
discuss where to obtain information on access to medi cines, their prices and availability, covering 
core questions on drug procurement,  pricing and relevant intellectua l property issues.  Arising from 
technical level dialogue between the organizati ons, the activity had been planned to lay the 
groundwork for continuing dialogue among the collabor ating organizations and their partners and the 
ongoing trilateral cooperation, which included the im plementation of the WHO Global Strategy and 
Plan of Action.  The event had heard the perspectives of the three Directors-General and from technical-level officials from the three Orga nizations, as well as representatives from global 
procurement agencies and NGO procurement initiati ves, other active NGOs and several industry 
perspectives.   
175. The WTO's technical-level contribution had been  to set out an overview of the practical 
information available on trade-related measures that had a bearing on all aspects of the access 
equation.  These included information on intell ectual property policy settings, procurement and 
competition policies, tariffs and regulatory matte rs ensuring the quality, safety and efficacy of 
medicines.  The aim had been to  provide as complete a factual picture as possible.  Hence the 
emphasis had been on strengthening the informati on base for practical cooperation on drug access and 
procurement questions.  Director-General Pascal Lamy  had commented that "global public health is a 
complex puzzle; getting it right is a teasing challe nge, involving effective use of the full set of 
applicable policy tools, but it is al so a practical craft, rather than a theoretical excursion meaning that 
we can and should learn from the actual experience of others in their efforts to create and disseminate 
needed treatments.  The pooled pers pective needs to cover the intern ational trade dimension but also 
consider domestic policies and prac tices, and above all the evolving st ate of the actual global disease 
burden, a priority setting for front-line treatments and patents for the production and dissemination of 
medicines". He had expressed the hope that the pr ogramme of the technical symposium would help 
illuminate this far bigger picture so that each organization could complete its specific areas of work with the benefit of greater understanding about how all the elements interacted and what priority 
targets should be aimed at, a task that could on ly be undertaken by public health colleagues. 
176. The symposium had not been intended as a po licy forum and accordingly no conclusions or 
outcomes had been intended to emerge.  However, the improved flow of data and the ideas for more 
effective use of diverse sources that had been explored during the symposium should allow for 
technical cooperation to be better designed and fo r a firmer empirical base for understanding access to 
medicines issues to be built.  It was clear th at, to progress the goal of access to medicines, 
strengthened cooperation and impr oved information resources from diverse resources would make a 
significant difference.  The technical symposium had reviewed a number of available resources of 
information, covering prices, availability and qualit y of medicines, concerning patents and the scope 
of patent coverage, and a range of trade and intellectual property policy issues and measures available 
in various WTO notifications and databases.  IP/C/57 
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  177. Based on the Secretariat's practical experience with technical assistance in the field, the 
current trend had appeared to be to try to ma rry the understanding about legal options and legal 
mechanisms with the broader pe rspective of procurement strate gies and an improved information 
base.  For example, since patents were national and territorial in scope, effective procurement 
practices entailed understanding what relevant patents were in for ce and in what jurisdictions.  
Similarly, information about pricing trends was helpful both in understanding the existing state of 
play regarding access and in undertaking practical  procurement activities.  Information about the 
broader regulatory framework, including on tariffs, ta xes, health regulation, competition policy, and 
intellectual property matters, helped to illumi nate the operational context of procurement 
programmes, in turn enabling them to be more e ffective and to derive better health impact from 
available resources.   
178. The representative of the WHO  presented his organization's experience from a public health 
perspective.  Among its most important missions was the improvement of access to quality essential 
health services and products, including essential me dicines, vaccines, diagnostics, medical devices 
and equipment, especially for disadvantaged peop le.  Reliable and sustainable access to health 
products was determined by different macro hea lth system factors.  These included strong, 
accountable and transparent health governance with well-developed health policies for national health 
systems, health financing, social protection mech anisms, trained and available health workforce, 
health care delivery infrastructure, and reliable health management and information systems. 
179. He said that, more specifically, access to medicines was determined by four factors:  
(i)rational selection of medicines;  (ii) affordable pri ces;  (iii) sustainable financing;  and (iv) reliable 
supply systems.  The rational selection of medicines required a country to decide, according to 
well-defined criteria, which medicines were most impor tant to meet existing public health challenges.  
Through its model list of essential medicines, WHO provided guidance to member states in the 
development of their national essential medicine lists .  An essential medicine had to be a safe and 
effective product and should represent the best rati onal choice, regardless of its price, to address a 
specific health problem.  As regards affordab le prices, while in high-income countries a high 
percentage of expenditures on medicines was publicly financed or reimbursed by  health insurance, a 
high percentage of expenditure came directly fro m the pockets of patients in low- and many 
middle-income countries.  The public sector was not alwa ys a viable alternative.  In a number of low- 
and middle-income countries, the average availability  of medicines in public health facilities turned 
around 35 per cent.  When patients therefore had to tu rn to private pharmacies, the price of medicines 
became one of the most important determinants of access to medicines.  With respect to sustainable 
financing, per capita expenditure on medicines in re al terms remained regrettably very low in poor 
countries, despite governments spending a large pr oportion of recurrent health budgets on buying 
medicines.  As regards reliable medicine s upply systems, these included forecasting needs, 
procurement, storage, transporta tion and inventory keeping of medicines.  All these areas remained 
weak in many developing countries.  Without investing in and improving supply systems, access to 
medicines would remain a formidable challenge. 
180. The representative of the WHO noted that hi s organization was involved with its member 
states in improving access to medicines in each of those four areas, both by developing norms and standards, and by providing direct technical assistan ce.  It used availability and prices of medicines as 
indicators to measure access to medicines.  Looking at access to high-priced patent-protected essential 
medicines, especially in countries with no or limited manufacturing capacity, he noted that more than 
90 per cent of medicines on the WHO model list of essential medicines were not patent-protected.  
Nevertheless, a majority of patients in low-income countries continued to suffer and to die due to lack 
of access to treatment interventions, including lack of supply of generic medicines.  Nearly 30,000 
children died every day from diseases that could easily be treated if they had access to a range of basic 
patent-free essential medicines.  Also 1.8 million child ren under the age of five years died every year 
of pneumonia alone that could be treated with chea p inexpensive antibiotics.  Only 20 per cent of IP/C/57 
Page 42  
 
  children received these antibiotics.   This was a long and tragic list of circumstances where 
inexpensive generic medicines were available, but did not get to the people when they needed them 
the most.  These issues needed urgent attention. 
181. High prices of patent-protected essential medicines also constituted a barrier to access to 
medicines, especially in the case  of second-line HIV/AIDS medicines and tuberculosis in Africa and 
other poor countries and for non-communicable diseases like cancer.  Generic competition in the 
market was one of the most efficient mechanisms to  bring prices down, as seen in the case of first-line 
antiretroviral medicines for the treatment of HIV/AI DS.  Because of generic competition, the cost of 
one year of treatment for one patient with first- line antiretroviral medicines had dropped from more 
than USD 10,000 to around USD 100 between 2002 and 2010.  This drastic decrease in the cost of 
medicines had resulted in increased access to those medicines.  As of December 2009, an estimated 
5.2 million people in low- and middle-income countries living with HIV had been receiving 
antiretroviral therapy, a twelve-fold increase sin ce 2003.  The importance of affordable prices of 
antiretroviral therapy would increase in the near fu ture.  Because of changes in the newly published 
WHO HIV treatment guidelines, the number of peop le for whom treatment would be needed could 
increase to 15 million. 
182. The System addressed a very specific situ ation when a country without sufficient 
manufacturing capacity wanted to procure a patent ed medical product, and there were no generic 
producers in other countries that could supply the product.  Other ways of obtaining the needed medicines could be explored before invoking the Syst em, for example, through a search of therapeutic 
equivalents which were not patent-protected or thr ough negotiation with the patent holder.  However, 
where no other possibility existed, the System could be legitimately put into action to procure the 
needed medicines.  The WHO Global Strategy and Plan of Action on Public Health, Innovation and 
Intellectual Property had been very explicit about the right of the member states to make optimal use 
of TRIPS flexibilities.  Element 5.2 of the Stra tegy had urged governments to "consider, where 
appropriate, taking necessary measures in countries w ith manufacturing capacity to facilitate through 
export, access to pharmaceutical products in countri es with insufficient or no manufacturing capacity 
in the pharmaceutical sector in a manner consistent with the TRIPS Agreement, the Doha Declaration 
and the WTO Decision of 30 August 2003". 
183. He noted that, although the System had rarely b een used to date, it might be considered more 
frequently in the future, given the changing requirem ents for new medicines to treat diseases, and the 
implementation of the TRIPS Agreement in member st ates.  A recent study had revealed that Indian 
generic manufacturers had accounted for more than 80 per cent of donor-funded annual purchase 
volumes of antiretroviral medicines between 2003 a nd 2008.  The implementation of full patent 
protection for pharmaceutical products in India and the approaching expiry of transition periods in LDCs might make it more difficult in the future to procure generic versions of  new medicines.  Under 
such circumstances, the System might assume a greate r significance.  He confirmed that to date the 
WHO had not formally received any request from any member state for technical assistance in the use 
of the System.  He concluded that access to medicines was determined by many factors and the situation was far from perfect even for those medici nes which were not patent-protected.  All possible 
legitimate measures had to be consid ered when access to patent-prot ected medicines of public health 
importance was at stake, especially when countries did not have sufficient local manufacturing capacity.  In such situations, the System was de finitely one of the possible options and it might 
become more important in the future.   
184. The representative of India
 appreciated the positive references that had been made to the 
Indian generic industry.  The latter had undoubtedly  brought a paradigm shift in changing the global 
discourse about access to life-saving medicines at affo rdable prices.  A recent study, published in the 
Journal of the International AIDS Society of Se ptember 2010, had noted that, over the last seven 
years, 80 per cent of donor-funded AIDS medicines had been supplied by Indian generic  IP/C/57 
 Page 43 
 
 
  manufacturers to developing countries.  The same stud y had also mentioned that the cost of the Indian 
generic version of the most commonly used fi rst-line adult regimen for HIV/AIDS treatment 
(Lamivudine/Nevirapine/Stavudine) had dropped from USD 404 per person per year in 2003 to 
USD 74 per person per year in 2008.  However, the cr edit could not be entirely attributed to the Indian 
generic industry, given that the largest generic manufacturer was in the European Union and the 
second largest in Israel.  But these manufacturers might  not be price-competitive in all generics.  He 
cautioned that the Indian generic industry was not  a panacea for addressing the reasons which had 
necessitated the establishment of the System.  Many  life-saving medicines were off-patent in India 
and therefore were readily available as generics.  He  noted that most first-line antiretroviral medicines 
predated the TRIPS Agreement and were therefore not patented in India.  This situation might change 
in the future, as more product patents were filed an d block-buster drugs were invented.  This might 
lead to a decline of the present generic advantag e, making the developing world, including the LDCs, 
dependent on high-priced patented drugs.  Switc hing to second-line antiretroviral medicines was at 
least three times more expensive, costing abou t USD 465 per person per year.  Possible third-line 
drugs like Etravirine, for which there was no generic alternative, cost USD 3,204 per person per year.  
Those medicines represented the real challenge for the System and other TRIPS flexibilities that could 
be invoked for public health reasons. 
185. With respect to voluntary contributions and tie red pricing by some developed Members, he 
noted that, while these attempts were appreciated, th ey were not lasting solutions.  The Report of the 
UN Special Rapporteur had indicated that one third of the world's population did not have access to 
affordable medicines.  The number of patients be ing treated for HIV/AIDS in developing countries 
had jumped to 5.2 million in 2010 from 400,000 in 2003.   Given the breadth of the problem, he noted 
that, while voluntary efforts and tiered pricing made an important contribution, they could not be the 
entire solution and did not obviate from the need to use the System.  He wondered whether the futile attempts of MSF and Ghana to use the System  through CAMR had had a chilling effect.   
186. The representative of India said that Articles 30 and 31(k) of the TRIPS Agreement 
represented possible alternatives to the use of th e System to achieve the objective of access to 
medicines.  During the preparatory work in the TRIPS Council which had led to the adoption of the System, the European Union had presented a con cept paper (IP/C/W/339).  One of the two possible 
solutions proposed had been the interpretation of "t he limited exceptions clause of Article 30 of the 
TRIPS Agreement in a way which would allow pr oduction for export, to certain countries and under 
certain conditions, of products needed to combat  serious public health problems".  The EU had 
acknowledged that "the advantage of this approach would be that it could fit within the flexibility 
offered by the existing TRIPS Agreement, without ther e being a need to amend any of its provisions".  
He noted that this option was always available to  Members.  In the September 2002 meeting of the 
TRIPS Council, the WHO representative had said that "t he solution...  that was most consistent with 
the principle was the provision of a limited exce ption under Article 30.  Such an exception would 
meet the mandate of the Declaration and provide e xpeditious authorization to third parties to make, 
sell, and export patented drugs and other technologies to meet public health needs" (IP/C/M/37). 
187. He noted that Article 31(k) performed the same  purpose as the Decision in that it waived the 
restriction imposed by Article 31(f) on compulsory  licensing for export when a Member issued a 
compulsory licence "to remedy a practice determined  after judicial or administrative process to be 
anti-competitive".  This provision had been used thr ee times in the last five years by a developed 
country Member of the EU.  Interestingly, the Member concerned had opted out as an importing 
country under the System.  Both Articles 30 and 31 (k) were existing provisions in TRIPS and were 
covered by Paragraph 4 of the Doha Declaration wh ich stated that "we reaffirm the right of WTO 
Members to use, to the full, the provisions of th e TRIPS Agreement, which provide flexibility for this 
purpose".  IP/C/57 
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  188. The representative of Japan
 believed that the objective of the System, which was to facilitate 
access to medicines by Members with insufficient or no manufacturing capacity in the pharmaceutical 
sector had to be kept in mind.  The System should no t be considered in an isolated manner but as part 
of a broader effort to contribute to access to medi cines.  At the trilateral Symposium on "Access to 
Medicines:  Pricing and Procurement Practices",  organized by the WHO, WIPO and WTO, it had 
been noted that elements other than intellectua l property rights were important to access medicines, 
such as procurement and tariffs.  It had also been noted that only five per cent of medicines included 
in the WHO list of essential medicines were protected by patent. 
189. He informed Members of Japan's efforts to  contribute to access to medicines.  In 
September 2010, Mr. Kan, the Prime Minister of Japan, had announced the "Kan commitment" to 
contribute USD 800 million  in the coming years to the Global Fund to Fight AIDS, tuberculosis and 
malaria which Japan had co-founded.  In orde r to accelerate progress towards the Millennium 
Development Goals by halting the spread of HIV/AI DS, tuberculosis and malaria, Japan would scale 
up effective interventions through the Global Fund .  To do so, it would promote an integrated 
approach, combining the Global Fund efforts with  strengthening health systems and maternal, 
newborn and child survival programmes, utilizing Japan's bilateral assistance.  Although the number 
of people receiving life-saving antiretroviral therapy against HIV/AIDS had increased from 0.4 million in 2003 to 5.2 million in 2009, he recognized that there was an urgent need for expanded 
efforts to address the issue.  His delegation had contributed USD 1.04 billion to the Global Fund.  Furthermore, as part of the Global Plan "Stop TB  2006-2015", Japan had provided anti-tuberculosis 
drugs and testing tools to tuberculosis-affected  countries, designated by the WHO as high burden 
countries.  Japan had also contributed to combati ng other infectious diseases, such as influenza and 
polio.  It had also provided an emergency gran t aid of approximately JPY 1.1 billion through the 
WHO in September 2009 to carry out immunizations in developing countries with the H1N1 influenza vaccine.  In addition, in order to prep are for a pandemic influenza, Japan was stockpiling 
and providing antiviral medicines in cooperation with ASEAN and the ASEM.  It supported the 
provision of polio vaccines through UNICEF to some  countries that had been designated as countries 
of prevalence.  The importance of local producti on in developing countries was also recognized.  
Japan had cooperated with the Government Pharma ceutical Organization of Thailand to locally 
produce influenza vaccine.  He reiterated the importa nce of access to medicines, and the importance 
of keeping the bigger picture in mind when discussing this issue. 
190. The representative of the United States
 said that the TRIPS Agreement provided an important 
balance between providing incentives to research a nd develop new medicines and promoting access to 
existing patented medicines.  The Doha Declaratio n had stated that the TRIPS Agreement "does not 
and should not prevent members from taking measures to  protect public health".  His delegation was a 
global leader on improving public health.  US funding for global health had increased significantly over time, particularly in the last decade.  Funding had more than doub led between 2004 and 2008, 
reaching USD 9.6 billion in 2008.  In 2009, the Un ited States had been the largest donor in the world 
for the global response to HIV/AIDS, accounting for more than half of disbursements by governments.  As part of the US Government 's global health programme, his delegation was 
committed to promoting equitable access to safe and effective medicines of assured quality around the 
world.  It was also fully committed to helping coun tries that were experiencing public health crises to 
find real and comprehensive solutions.   
191. He said that his delegation had strongly supported the General Council Decision of 
August 2003 to implement the Doha Declaration so that drugs could be exported under a compulsory 
licence under the terms set out in the Decision and the accompanying Chairman's Statement.  It had also lent strong support to the Protocol Amending the TRIPS Agreement in 2005 to make the System 
a permanent part of the Agreement and to appropr iately preserve reference to the Chairman's 
Statement.  He recalled that the System had been the result of robust discussions and had attracted the 
consensus of the Members;  other prior proposals ha d been left behind.  His delegation had been the  IP/C/57 
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  first Member to notify its acceptance of the amendmen t.  The System was intended to be only one tool 
to assist in promoting access to medicines and provided an important failsafe in Members work to improve access to medicines.  In the past, some dele gations had shared their view that the System had 
been used sub-optimally and that an analysis of its functioning was needed.  As his delegation had affirmed at previous meetings, the Council's a nnual review was the forum at which Members had 
intended reviews of the operation of the System to be conducted.  It was also the place where 
Members, who were the users of this intergove rnmental system, should share their experiences 
regarding any concerns. 
192. He noted that in the past some delegations had attached importance to the fact that the System 
had been used only once.  Counting the frequency of use was, however, not the right metric to 
measure the effectiveness of the System.  Instead, the results had to be evaluated.  Members needed to 
look at the extent to which medicines were reach ing affected populations.  With respect to that 
question, the number of times that Members had relied on the System as a safety valve mechanism did not provide the right focus.  Instead, the System should be viewed in its proper, larger prism.  This principle had been reflected in paragraph 2 of the Doha  Declaration.  He noted that the majority of the 
drugs on the WHO's Model List of Essential Medicines were off-patent.  Additionally, it was also 
important to recall that the System's development had been one element of a larger international 
exchange of ideas that WTO Member government s, the donor community, companies, and other 
stakeholders had had, and continue d to have, in order to improve access to medicines.  That work had 
led to real and measurable progress over the past d ecade in improving access to medicines.  Further, it 
had led to partnerships between  governments, between governments and stakeholders, and between 
stakeholders themselves. 
193. In his delegation's discussions with stakeholde rs across the spectrum, he had consistently 
heard that access to medicines was being improved th rough numerous means.  Those means included 
developed country policies and programmes that placed greater emphasis on building sustainable 
capacity in the public sectors of developed country  partners and at their national and community 
levels to provide basic services over the long term.  They also included efforts to expand research and 
development of innovative drugs and production cap acity for both innovator and generic drugs in 
developing countries.  Further, those means incl uded donations of health products by Members, the 
private sector, and international bodies, as well as tiered pricing, bulk purchase mechanisms, 
innovative licensing models and other measures by innovative and generic companies and multilateral 
bodies.  The United States, through the National Institut es of Health (NIH), had been the first patent 
holder to share its patents with the newly establishe d Medicines Patent Pool Foundation.  The initial 
contribution by the NIH and its co-patent owner, the University of Illinois, had embodied these 
commitments and had taken an important step toward making affordable and appropriate HIV 
medicines available to patients around the world.  It had built on the US President's previous 
commitment to support humanitarian licensing polic ies to ensure that medications developed with 
taxpayer dollars were available off-patent in developing countries. 
194. With respect to measures undertaken by innova tive and generic companies to meet the needs 
of LDCs and others, he noted that in many cases, innovator companies simply did not apply for patent 
protection in many developing countries.  There ha d been widespread tiered pricing of pharmaceutical 
products tied to individual and sub-re gional developing country markets.  Tiered pricing was linking 
the price of a pharmaceutical product in a market to what the consumer or purchasing government 
could afford to pay.  While tiered pricing w as not a new strategy, its frequency of use had 
dramatically increased in the past decade.  For example, Bristol Myers Squibb, partnering with many 
Health Ministries, had announced a number of years ago that it would make all of its HIV medicines available at no-profit prices in sub-Saharan A frica.  In 2005, the company had announced that 
paediatric formulations would be priced below co st, in order to further reduce barriers to provide 
access to this treatment.  He understood that other companies, such as GlaxoSmithKline, had offered 
certain antiretroviral drugs at not-for-profit prices in 64 different countries.  A number of other IP/C/57 
Page 46  
 
  companies were reportedly working together to provid e a "single tablet a day" product at significantly 
reduced prices.  These examples made it clear that  private actors were improving access to medicines 
in a manner that simply had not been present five to seven years ago. 
195. Many patent owners also reported that they ha d partnerships with generic manufacturers to 
make their products more generally available.  They relied upon these generic manufacturers, often in 
developing countries, to scale up their manufacturing.  The partnership between Gilead, an innovative 
pharmaceutical company, and Indian and South A frican generic manufacturers represented one 
example in this regard.  It had increased the num ber of people receiving various treatments from 100 
at the time of the Doha Declaration in 2003, to 7 00,000 in 2010.  Gilead had entered into licensing 
agreements with those pharmaceutic al companies to transfer its patented technology for the 
formulation of the medicine.  These treatments addressed HIV infection and chronic Hepatitis B in 
adults.  With respect to its Indian partners, Gil ead had entered into licensing agreements to produce 
and distribute a generic version of the drug to 95 low-income countries much earlier than otherwise possible, due to India's production capacity and ca pable generics industry.  The licensing revenue 
from these agreements was also reinvested to fund medical education, safety reporting, and product 
registration/marketing approval in destination market s.  He noted that a number of companies around 
the world had granted licences to generic pharmaceutical  companies to make generic versions of their 
drugs.  He understood that licensing contracts were being explored by pharmaceutical companies in Bangladesh, Ethiopia, Kenya, Tanzania and Zimbabwe, as well as other countries.   
196. Another example of a partnership between innova tors and generics was the global Meningitis 
Vaccine Project (MVP).  The MVP had been establis hed in 2001, using tech nology licensed by the 
NIH.  In 2001 and 2002, the MVP had approached  various vaccine manufactures, seeking a 
manufacturer who could agree to manufacture the vaccine for 50 cents a dose, the price that NIH had been told by countries in Sub-Saharan Africa was n ecessary for the vaccine to be affordable in their 
marketplaces.  The Serum Institute of India had accep ted the challenge, and, after about eight years of 
work, had begun to ship the vaccine to Mali,  Burkina Faso, and neighbouring Niger in 
September 2010.  This eight year lag did reveal a larg er point, i.e.  that the procurement of medicines 
was a long process.  Any measure of length of obtaining a licence under the System should take this into account.  The results of this collaboration sp oke for themselves.  With respect to the MVP 
project, over a recent 17-day period, over 1 million pe ople had been vaccinated.  The target was to 
distribute 40 million doses.  The Gilead and MVP ap proaches were just two examples of partnership 
trends that were increasing and delivering real results.  These approaches had not existed ten or 
15 years ago.  There were many such cutting-edge partnerships that were promoting access to 
medicines.  Other similar partnership trends that had been reported included an increase in the number 
of research collaborations targeting areas of need  and increased voluntary sharing of intellectual 
property, such as "compound libraries" for research purposes.  One company had launched a knowledge pool, now run independently by a third pa rty, that had placed approximately 80 patent 
families in a pool to help others devel op new medicines for neglected diseases.   
197. In addition to collaboration with innovator co mpanies, the generic drug industries had also 
had a significant role to play in improving access.  For example, generic companies were engaging in more research activities for adapting existing products to the needs of developing countries as well as 
assisting in capacity advancement in poor countries.  Many of those partnerships also provided jobs, 
access to doctors and nurses, and training for medica l staff, schools and hospitals.  He said that the 
ability to patent an invention was critical to ensu re that there was an incentive for developing the 
medicine and that its benefits c ould be shared widely.  The devel opment of new, life-saving drugs was 
a risky and expensive process, and it was necessary to provide incentives for the private sector to 
undertake this effort.  Intellectual property rights were essential to provide this incentive so that new 
drugs could be brought to the market.  Moreover, patent systems could provide important incentives 
to reward innovators who had identified ways to  adapt medicines to many different challenging 
circumstances, such as a lack of refrigeration or a need for more patient-friendly ways of  IP/C/57 
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  administering a drug that might be particularly rele vant in developing country markets.  Many actors 
were working to promote access to medicines.  The intellectual property system played a critical role 
in assisting this effort.   
198. Time had shown that intellectual property rights were not often the determining factor in the 
larger issue of access to medicines, as had someti mes been asserted.  Many complex factors hampered 
access to medicines in developing countries, in cluding sub-optimal procur ement systems and poor 
distribution networks for medicines, caused by l ack of basic infrastructure, hospitals, clinics and 
healthcare professionals, among others.  The goal of  equitable access to medicines was not achievable 
or sustainable without fostering improvements to the health systems themselves to ensure that patients 
could actually receive the drugs.  Additionally, systemic problems, taxes and tariffs on imported 
medicines, and a lack of cold-chain storage, we re often overlooked problems in many multilateral 
discussions. 
199. With respect to problems that inhibited access to medicines, he noted that in some cases taxes 
or tariffs were levied on products being supplied at  cost, or on donated products, the cost of which 
was passed directly to patients.  Moreover, hea lth care was often delivered far from the community 
being served.  Weak drug procurement and deliv ery systems were another barrier to access to 
medicines.  Lack of transportation and infrastructur e also made it difficult to distribute pharmaceutical 
products and for a patient to see a doctor.  B acklogs, regulatory redundancy, as well as other non-
tariff barriers also hindered the distribution of both generic and innovative drugs where they were 
most needed.  Finally, if the healthcare system wa s flooded with counterfeit pr oducts, true access was 
not achieved.  Because of weak regulatory regime s and global criminal networks, counterfeit and 
substandard medicines harmed or killed sick people across the globe, with the developing world being 
disproportionately affected.  The WHO had estimated that "in over 50 per cent of cases, medicines purchased over the Internet from illegal websites that conceal their physical address have been found 
to be counterfeit".  These were all problems that co uld be solved.  Many of the issues would require 
action by both developed and devel oping countries.  It was clear that, without accounting for the full 
range of problems that existed, Members coul d not make the improvements that would foster 
improved access. 
200. With respect to some of the solutions with wh ich the United States was involved, he said that 
on 22 September 2010, President Obama had announ ced a new US global development policy, the 
first ever for a US Administration.  Through the policy, President Obama had made it clear that sustainable development was a long-term propos ition, and progress depended on the choices of 
political leaders and the quality of institutions in developing countries.  Where leaders governed 
responsibly, set in place good policies, and made i nvestments conducive to development, sustainable 
outcomes could be achieved.  Where those conditi ons were absent, it was difficult to engineer 
sustained progress, no matter how good the intentions  or the extent of engagement.  The policy had 
placed greater emphasis on building sustainable capacity  in the public sectors of US partners and at 
their national and community levels to provide basi c services over the long term.  The United States 
would continue to provide medicine, emergency food aid, humanitarian relief and other assistance 
where it was urgently needed.  But the United States would also strive to help increase the capacity of 
its partners to meet those needs by investing in systemic solutions for issues such as service delivery 
and public administration.  President Obama's six-year, USD 63 billion Global Health Initiative (GHI), had focused on sustainable service delivery wh ere the needs were greatest and the conditions 
were right to build effective health service deliver y systems.  As to shortages of skilled health care 
professionals, the US Government, as well as ma ny private companies, had undertaken significant 
efforts to improve healthcare systems in developing countries.  In the President's Emergency Plan for 
AIDS Relief (PEPFAR) and the President's Malaria Initiative (PMI), the United States was training a 
significant number of health workers in support of su stainable health systems.  The United States was 
also a leader in the implementation of task-shi fting initiatives in Africa.  The PEPFAR had promoted 
access to medicines and other products through ma ny means, including by improving supply chain IP/C/57 
Page 48  
 
  management.  This approach was saving lives; through PEPFAR, 2.5 million people were being 
supported for life-saving antiretroviral treatment. 
201. The PMI was working to improve access to ma laria medicines through their procurement and 
distribution in the 15 PMI focus countries (Angol a, Tanzania, Uganda, Malawi, Mozambique, 
Rwanda, Senegal, Benin, Ethiopia, Ghana, Ke nya, Liberia, Madagascar, Mali and Zambia), 
distributing over 80 million treatments.  With resp ect to government tariffs, as part of the WTO 
NAMA negotiations, Switzerland, Singapore, the Un ited States and Chinese Taipei had proposed an 
Enhanced Healthcare Initiative for Members to jointly reduce or eliminate tariffs on medicines and 
key medical equipment and supplies.  He hoped that  other Members would join in this effort, as it 
would result in lower medicine prices.  Simila rly, the use of transparent, competitive and non-
discriminatory procurement procedures and practi ces would provide governments with more choices 
from a broader array of suppliers that could mean  lower prices and more effective use of limited 
financial resources.  Access to me dicines was a complex issue that required a multifaceted, and often 
multi-sectoral approach, that address ed all aspects in a meaningful way.  The System must be located 
in this larger prism.  The United States' experi ences on approaches that were producing results were 
an illustration that Members should not focus only on reliance on the System as a proper or 
meaningful gauge of its operation. 
202. The representative of Canada
 said that the trilateral Symposium jointly organized by the 
WTO, WHO and WIPO had been very useful.  He disagreed with India's characterization of the Ghana case as having had a "chilling effect".  Acco rding to his information, when Indian generic 
firms had first brought TriAvir to the market, the tr iple ARV combination which had eventually been 
exported to Rwanda had been priced between 30 a nd 40 cents.  There had also been shipments from 
Indian generic firms to African countries.  When  Apotex had become a viable option and CAMR 
could be exercised by interested parties, the price of TriAvir from Indian firms had dropped substantially to 19 to 20 cents per pill.  Instead of a chilling effect, CAMR and the System as a whole 
could have had a beneficial effect on price. 
203. Since the System had come into  existence, a number of international procurement systems 
had been developed, such as the Clinton Foundation,  which had been key to delivering medicines to 
people in need.  He asked potential importing count ries whether they had taken advantage of such 
international procurement systems and if they coul d relate their experiences in this regard.  Many 
pharmaceutical companies also had charitable programmes by which they donated medicines.  This alternative was actively promoted by Canada thr ough tax incentives made available to brand name 
and generic pharmaceutical companies which donated medicines.  However, tariffs had a chilling 
effect on such initiatives.  It would therefore be interesting to hear from potential importing Members 
whether they still imposed tariffs or duties on donate d medicines which were imported.  There also 
continued to be growing manufact uring capacities of the pharmaceu tical industry in developing 
countries which were able to produce drugs at lower costs.  This had been a factor in the Rwanda 
case.  His delegation was interested to learn whether Members had increased their domestic 
manufacturing capacities since 2003. 
204. Voluntary licences were another available a lternative for obtaining essential medicines.  
Although the information was difficult to obtain, as these were transactions between private parties, 
there was some evidence that vol untary licences were being successfu lly deployed.  In the Rwanda 
case, if a voluntary licence had been secured by Apot ex, it would not have been necessary for Apotex 
to request an export authorization from the Commissi oner of Patents.  Nevertheless, this would still 
have constituted a success for CAMR.  With respect to Canada's 2007 Statutory Report on CAMR, he 
noted that it had stated that Canada should continue to pursue non-legislative measures to improve access to medicines in the developing world.  The Canadian International Development Agency 
(CIDA) was working with the global community to  address health needs in developing countries.  
ClDA worked with qualified, experienced organizations  and partners to improve health in the most  IP/C/57 
 Page 49 
 
 
  effective and cost-efficient way.  For example,  Canada was a founding donor of the global drug 
facility in 2001 and had been the largest single donor country for first-line tuberculosis drugs since the 
facility had been created.  The global drug fac ility, a programme of the "Stop TB" Partnership, 
worked to improve access, supply and distribution of  low-cost quality-assured anti-tuberculosis drugs 
in developing countries and was the only bulk procurer  of such drugs.  CIDA also provided significant 
support for initiatives such as the GAVI Alliance, th e WHO's universal access plan, and the Global 
Fund to fight AIDS, tuberculosis and malaria.  He was pleased to note that Canada's commitment to 
the Global Fund had recently been enhanced.  In September 2010, Canada ha d announced that an 
additional commitment of USD 540 million would be provi ded over the next three years.  This was in 
addition to the USD 978.4 million that Canada ha d already committed and disbursed to the Global 
Fund since 2002. 
205. Under its G8 Presidency in 2010, Canada ha d championed the Muskoka initiative, a major 
global effort to improve maternal, newborn and child  health in developing countries.  Eighty per cent 
of Canada's contribution of USD 1.1 billion would go to sub-Saharan Africa which had the greatest 
burden of maternal and child mortality.  However,  some countries simply could not afford essential 
medicines, no matter how low the costs were.  Moreover, the health delivery systems in some 
developing countries were inadequate to deliver and administer medicines, among others, because of 
an insufficient number of well-trained medical staff and lack of modern infrastructure.  This was 
another reminder that the main problems of access to medicines were the result of poverty, not patent 
laws. 
206. With respect to counterfeit and sub-standard me dicines, the representative of Canada referred 
to a statement by Minister H.E. Prof. Dr. Hatem El-Gabaly of Egypt.  At a conference in 2009, the 
Minister had provided some important remarks regarding the scourge that counterfeit and sub-
standard medicines had had with respect to their effe ct on the health of citizens.  He had also made 
some remarks about the economic aspects.  He  quoted the Minister who had said: "counterfeit 
medicines also inflict serious damage and injury  to national economies and manufacturers.  These 
negative economic consequences are not limited to depriving legitimate businesses and their workers 
of income.  Discouraging innovation and creativity  can provide an easy source of revenue for 
organized crime, but they also entail loss of nati onal tax revenues.  As su ch, both governments and the 
private sector stand to lose from proliferation of trade in counterfeit medicines.  As part of our collective endeavours to address this global challenge , we must be cognizant of the underlying factors 
that feed such illicit trade.  These factors can be  technical, economic or legal.  However, the 
inescapable fact is that counterfeiting of medicines is a lucrative business due to the continued high 
demand for medicines and low production costs.  Expe rts indicate that when prices of medicine are 
high and price differentials betwee n identical products exist, there is a greater incentive for the 
consumer to seek medicines outside the normal supply  system.  In this context, poverty and lack of 
awareness appear as important issues to be addressed in our fight against counterfeit medicines.  No 
country is immune from the threat posed by co unterfeit medicine, and Egypt is no exception.  
Therefore it is our firm conviction that counterfeiting medicines, including the entire range of activities, from manufacturing to providing them to patients, is a serious criminal offence that puts human lives at risk and undermines the credibility of health systems.  Let me shed some light on our 
response strategy.  At the international level, Egyp t supports global efforts aiming at eradication of the 
threat of counterfeit medicines.  In the face of th is trans-boundary threat, we continually coordinate 
with our international partners to design more effective collaboration mechanisms that involve 
international organizations, enforcement agencies,  national drug regulatory authorities, customs and 
associations for consumer protection.  We also pr omote sharing of information and exchanging best 
practices amongst all stakeholders.  More importantly, tightening border controls to diminish the risk 
of trans-shipment of counterfeit medicines should be a priority for regional and international 
cooperation." The representative of Canada asked wh ether the delegation of Egypt could expand upon 
these timely initiatives of the Egyptian Government. IP/C/57 
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  207. He also quoted the Indian Minister of Health  and Family Welfare, Ghulam Nabi Azad, who 
had stated: "I propose to introduce a whistleblower po licy to involve the public to provide information 
on any kind of unlawful activity in the manufacture of drugs.  There is no dearth of good intentioned people who may wish to work for his country's in terests as a whistleblower in eradicating this 
menace.  People's participation is imperative in this  regard." The media report had also indicated that 
a country-wide survey in India was under way to assess the exact size of India's spurious counterfeit 
drug industry.  The study had apparently alr eady identified 61 popular drug brands from nine 
therapeutic drug categories that were being tested .  Canada asked the dele gation of India whether 
there were any specific results from this study that could be shared with Members.  Apparently, the 
Indian Health Ministry had estimated that 5 per cen t of the drugs sold in India were counterfeit while 
0.3 per cent were spurious.  A counterfeit medicine was one that had no active ingredient or was an 
expired drug that had been relabelled or sold.  It was different from a fake drug which might resemble 
the original in any way, according to the report.  The Minister had also stated that the Drugs and 
Cosmetics Act had recently been amended to prov ide stricter penalties for offences under the Act, 
particularly to those engaged in  making spurious, adulterated, mi sbranded and sub-standard drugs.  
The maximum penalty was life imprisonment and a fine of three times the value of confiscated goods.  
Some of the offences were now cognizable and non-b ailable.  His delegation was interested in any 
updates about this particular Act and any other Indian initiatives. 
208. The representative of Brazil
 shared her delegation's experien ce with the System.  Paragraph 7 
of the Decision of August 2003 had established that "Members recognize the desirability of promoting 
the transfer of technology and capacity building in the pharmaceutical sector in order to overcome the 
problem identified in paragraph 6 of the Declara tion".  Her delegation regarded this as an essential 
element of the Decision.  While not directly related to the System's implementation, she referred to a recent initiative funded by Brazil in an attempt to solve the problem of countries with limited 
manufacturing capacity.  The Brazilian Governme nt was helping Mozambique set up a small 
manufacturing unit for the production of first-line an tiretroviral medicines based on the portfolio of 
drugs produced by the Oswaldo Cruz Foundation.  The output of this unit was initially intended for 
the local market.  In the future, the producing pl atform of Mozambique might also supply other 
neighbouring markets. 
209. The representative of Cuba
 said that her delegation was not in a position to accept the 
Protocol Amending the TRIPS Agreement until the ope ration of the System had proven to be fully 
effective.  Moreover, regulatory aspects, incl uding a quality examination regarding safety and 
efficacy, did not form part of the System.  Other as pects had to be clarified which had a bearing on the 
lengthy period needed to manufacture and expor t pharmaceutical products under the System.  The 
preparation and approval by the relevant government  authorities of the legal instrument that was 
required to apply the System at national level en tailed a complex process.  There was therefore no 
justification for undertaking such a process until it ha d been demonstrated that the System complied 
with the objectives of paragraph 6 of the Doha Declaration.  Some Members considered this system to 
be an historic milestone which it undoubtedly was.  The mandatory patent protection of 
pharmaceutical products had made it necessary to find a solution to ensure that profit-making interests 
of patent holders were not maximized  to the detriment of the right to life and health.  Nevertheless, 
the System was still far from proving its practical effectiveness.  Certain clarifications made in this discussion should have already been addressed by the Decision establishing the System.  She said that 
the System had also been distorted bilaterally by  developed countries through free trade agreements.   
210. The representative of the European Union
 said that the System was a measure among many 
others that could contribute to improving access to medicines in the developing world.  He 
highlighted some of the reasons that could explain why the System had not been used frequently.  First, a number of medicines were simply no long under patent protection.  For those medicines, there 
was therefore no need for a compulsory licence, and therefore no need to invoke the System.  
Secondly, least developed country Members were not obliged to implement their obligations under  IP/C/57 
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  the TRIPS Agreement regarding patents and undiscl osed information in the pharmaceutical sector 
until 1 January 2016.  Until then, those countries who had not implemented the TRIPS Agreement 
could import medicines without making use of compulso ry licensing.  Finally, developing countries in 
need could use all available channels to ensure access to affordable medicines.  Those included the 
use of the existing TRIPS flexibilities, direct nego tiations with the pharmaceutical companies, public-
private partnerships and donations.  With regard to the efforts made by the European Union to 
facilitate access to medicines, he recalled that his delegation was taking an active part in promoting 
access to medicines in developing countries.  It was the biggest provider of resources to support health 
policies in developing countries.  Projects and programmes funded by the European Union in developing countries covered a wide range of ac tivities, research, production, procurement and 
delivery, including quality control.  It was as sociated with a number of WHO programmes for 
research and development and capacity building.  It was also one of the oldest and biggest 
contributors to the Global Fund to fight AIDS, Tuberculosis and Malari a and had donated EUR 872 
million since 2002.  Under its cooperation programme  in the form of the Seventh Research and 
Development Framework Progra mme covering the period 2007-2013, the European Union had 
allocated a total of EUR 6.1 billion to help resear ch and development worldwide.  Moreover, it had 
also set up a tiered pricing mechanism for the suppl y of cheaper medicines to developing countries.  
His delegation remained fully committed to fac ilitating access of medicines in the developing world 
and to making the System work. 
211. The representative of Colombia
 noted that his delegation was interested in examining whether 
the international rules that Members had agreed  upon genuinely facilitated access to medicines.  
Access to medicines involved correctly assessing the needs of the population and undertaking 
research, development, production and supply of medi cines to meet those n eeds, so as to ensure 
timely access to the medicines in su fficient quantities and at affordable prices for all.  The regulatory 
environment should be both favourable to the industry and in the interests of public health.  A balance 
needed to be found between the in centives for the industry and the cr eation of a competitive market.  
The System had sought to achieve this goal in res ponse to the specific situation of Members who had 
insufficient or no manufacturing capacities in the ph armaceutical sector and faced difficulties in 
making effective use of compulsory licensing. 
212. He questioned, however, whether the System wa s the only instrument and whether its design 
and implementation were optimal for achieving the goa l of supporting public health.  With respect to 
the first question, the System was clearly not th e only intellectual property instrument aimed at 
attaining these goals.  Compulsory licensing, more  stringent patentability criteria, exceptions to 
patentability, parallel imports and control of abuse of  intellectual property rights by right owners were 
other valid tools for protecting public health.  Likewise, there were mechanisms beyond the 
intellectual property sphere that were directed to wards the same objective.  Accurate and widely 
available price information and mechanisms to prom ote competition were powerful tools to that end.  
With respect to the second question, his delegation viewed the System as both limited and complex.  
Moreover, its requirements had led to delays and costs which made it a somewhat unattractive option 
presently.  Those aspects should be further discussed in the interests of achieving an effective 
implementation of the System.  He noted that only 30 Members had notified their acceptance of the Protocol Amending the TRIPS Agreement.  Colomb ia had notified its acceptance in August 2009.  If 
the rate of adoption continued at its current pace of  six Members per year since 2008, it would take at 
least three more years for this flex ibility to become a permanent part of the Agreement.  He urged all 
Members whose domestic acceptance procedures were  still under way to complete the process. 
213. Referring to the statement by his Health Mini ster which had been quoted by Canada, the 
representative of Egypt
 outlined his delegation's perspective on th e issue of counterfeit medicines.  He 
referred to a statement made by Minister Hatem El gabaly at the 63rd Session of the World Health 
Assembly.  On this occasion, he had said that "t he quality, safety, and efficacy of medicines is 
a primary concern of national drug regulatory regim es.  Likewise, the World Health Organization has IP/C/57 
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  an important role to undertake in supporting these  effo rts of its member States.  We believe that the 
activities of the WHO in this regard should be given mo re focus and clarity.  There needs to be a clear 
distinction between on one hand, ensuring the qualit y, safety and efficacy of medicine, which is a 
public health issue directly within the remit of  the WHO, and on the other hand, the issue of 
counterfeiting, which is a term pertaining to the field of intellectual property, and specifically, a 
problem of trademark violation, as referred to in  the World Trade Organization TRIPS Agreement.  
As such, this latter issue should be dealt with unde r relevant national IP legislation, and pertinent 
national IP enforcement procedures, and multilaterally,  it should be dealt with at the more competent 
Geneva-based organizations, chiefly the WTO and WI PO.  At the WHO, attention should be paid and 
solutions must be urgently found from a pub lic health perspective and not through the 
lens of intellectual property rights.  By bringing mo re clarity to the issue at hand, we can note that 
sub-standard medicines lacking in quality, safety and efficacy represent a far larger risk to public 
health than counterfeit medicines.  These two classe s should not be confounded and particularly so at 
the WHO which has a clear mandate relating to public health."  
214. The representative of Venezuela
 noted that the delegation of Canada had described poverty as 
the main problem for access to medicines.  He questi oned this statement, noting that poor patients in 
developing countries sometimes resorted to counterfe it drugs out of despair.  The problem therefore 
was high prices applied by multinational compani es which they placed above the public health 
interests of the poorest nations.   
215. In reaction to the quotation of the Indian Hea lth Minister by the delegation of Canada, the 
representative of India  noted that his Government attached hi gh importance to the issue of spurious, 
sub-standard and falsified medicines, which posed  a big challenge for public health and access to 
medicines.  This was backed by the Minister's st atement which had referred to deterrent punishments 
under the Drugs and Cosmetics Act.  With respect to  counterfeit medicines, he endorsed the statement 
made by the delegation of Egypt.  At the World Health Assembly, as well as at other international 
fora, his delegation had deplored the deliberat e confusion which was being created between 
intellectual property rights and public health-related issues.   
216. The representative of Ecuador  queried what budgets private actors had for the distribution of 
essential medicines, compared with the budgets of member  states.  He also asked  to what extent such 
donations and grants made by pharmaceutical comp anies which were usually profit-driven businesses 
could be compared.  He was also interested to know more about questions of government procurement.  In Ecuador, a compulsory licence had been issued and in less than a month contracts 
had been exchanged.  Moreover, he asked how many voluntary licences had been granted and what 
the time-frame was for the negotiations leading to  the grant of such licences.  As regards the 
discussion of benefits, he noted that these were a bout access to essential medicines and human lives at 
stake, not about trade and profitability.  He suppor ted the statement by the delegation of Venezuela 
regarding poverty and access.  He said that issues re lated to public interest as discussed in the TRIPS 
Council were the responsibility of all Members a nd therefore different from donations from private 
business, companies or initiatives.  With respect to counterfeit and sub-standard medicines, he 
cautioned Members not to target or undermine generic medicines. 
217. The representative of Norway
 said that his delegation fully supported the intention behind the 
System which had been duly implemented domestica lly.  He noted that his delegation was a major 
donor to a number of public and private partnershi ps that had improved access to medicines such as 
the Global Fund to fight AIDS, Tuberculosis and Malaria, the GAVI Alliance and the drug purchase 
facility UNITAID. 
218. The representative of Switzerland  supported a number of points made by the US delegation.  
In particular, his delegation had co-sponsored the enhanced health care initiative which targeted the 
elimination of tariffs on medicines and medical devi ces in the WTO.  An obvious alternative to the  IP/C/57 
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  System was a favourable outcome of procurement ne gotiations with the patent holder itself.  This 
would result in direct delivery from the patent holde r or alternatively, in the grant of a voluntary 
licence to a potential manufacturer, who would, in cooperation with the patent right holder, provide 
the medicines required to the recipient country at a mo re affordable price.  This alternative was often 
a more expeditious process and a better guarantee for the safety and efficacy of the medicines.  The 
Government's position to negotiate the terms of such a licence agreement was strengthened by the 
System's very existence as an altern ative to such a mutually agreed so lution with the right holder.  The 
System enabled countries without manufacturing cap acity in the pharmaceutical sector to effectively 
consider issuing a compulsory licence as a polic y tool and as a fallback option to contractual 
agreements. 
219. However, to advocate compulsory licences, wh ether under Article 31 or the new Article 31bis 
of the TRIPS Agreement as a simple solution to pr ovide easy and sustainable access to medicines was 
not only simplistic but also a misleading message to  countries in need of medicines to address a 
pressing public health problem.  Compulsory licences posed a number of practical problems that were time consuming to solve.  The search for an appropr iate generic manufacturer who was ready, capable 
and available to produce a generic medicine was a ch allenge in itself and could be time-consuming.  
Some generic producers were also not in a position to  provide more affordable or competitive prices.  
The issue of high-quality medicines and regulatory review of the quality and efficacy of medicines produced under a compulsory licence constituted anothe r set of considerable challenges.  It would 
therefore be simplistic to present compulsory licences as a panacea for access to medicines for 
developing countries.  Where it was possible to find a mutually agreeable and affordable solution for 
the supply of the needed medicines by the original manufacturer holding the patent right, this was the 
most efficient and expeditious solution for a country  facing an urgent public health problem.  Thus, 
the production lines would already be there and the r espect of tested and reliable standards regarding 
health and efficacy would be assured.  Howeve r, sometimes a compulsory licence, which was 
available to Members under the TRIPS Agreement,  was a useful policy tool.  The System had 
facilitated the use of compulsory licensing by WT O Members without manufacturing capacities in the 
pharmaceutical sector on a level playi ng field with all other Members. 
220. With respect to India's intervention, he noted that in 2002, Article 30 TRIPS had been 
considered as a potential solution.  However, this  approach had been quickly discarded, and had not 
reached consensus.  In any event, his delegation did not consider Article 30 to be a viable alternative 
to the System which covered new ground.   
221. The representative of Australia
 recalled that the System had been developed to improve the 
ability of countries without manufacturing capacity to  access affordable medicin es.  It had not been 
intended to be a panacea solution to the problem of  access to medicines.  Her delegation would be 
interested to hear from those Members who ha d spoken of occasions when the availability of 
alternative sources of medicine, including generics, had vitiated their need to utilize the System.  The 
availability of effective alternatives to the System  provided no evidence of its  failure, but constituted a 
useful example of alternative pathways through wh ich access to medicines could be realized.  The 
operation of the System could therefore not be c onsidered in a vacuum, as it represented but one 
weapon in the armoury of mechanisms and policies intended to improve access to medicines.  Any 
assessment of its effectiveness had to take into account the specificities of what the System was 
intended for and was able to achieve, as well as the wa y in which it impacted upon, and was impacted 
upon by, a diverse range of bigger picture issues af fecting access to medicines.  These were much 
broader than the intellectual property issues discussed  in the Council.  They included the rate and 
relevance of innovation, the reliability of procurem ent and supply chains at both the national and 
international level and the safety, affordability and appropriate use of medicines.  These and other 
issues were affected by and had implications for the System's operation.  They were also being 
considered in other multilateral fora, such as under the WHO's Global Strategy and Action Plan on 
Innovation, Public Health and Inte llectual Property.  These discussi ons could usefully inform the IP/C/57 
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  Council's debate, including with respect to how WTO Members could more effectively use the 
system.  Her delegation looked forward to continuing  the consideration of the System's operation in 
the context of the broader discussion of access to me dicines, bearing in mind the issues which could 
be addressed by the System. 
6. Next steps and recommendations 
222. The Chairman
 said that the purpose of this topic was to provide the Council an opportunity to 
discuss whether there was a need for follow-up to th e present annual review and, if so, what it should 
be. 
223. The representative of India  noted that the meeting had provided a good opportunity to discuss 
in greater detail the implementation of the System and several other associated issues, but discussions 
had not been exhaustive.  With the track record  of a single use in seven years, he remained 
unconvinced that the System was workable.  It could certainly not respond to public health 
emergencies.  He regretted that  key stakeholders, including phar maceutical companies and civil 
society organizations which had first-hand experience  of using or attempting to use the System, had 
not participated in the discussion.  At the Counc il's previous meeting, some developed country 
Members had made a discussion among Members a prer equisite to enlarging participation.  He 
considered that this condition had now been me t.  He therefore recommended that a dedicated 
workshop be held with an enlarged participati on, including pharmaceutical companies and civil 
society organizations.  Further details regarding ma tters such as participation, timing and scope should 
be discussed in informal consultati ons to be held by the Chair. 
224. Moreover, he recommended that international or ganizations, which had made presentations at 
the meeting, be invited to respond to the remaini ng questions at the Council's next meeting.  In 
particular, he requested the WHO to prepare a de tailed report on the coverage of flexibilities in its 
technical assistance activities.  He also requested  the delegation of Canada to report on further 
developments regarding efforts to amend CAMR.  In addition, Members might make submissions for 
future focused discussions.  He also invited deve loped country Members to report at the Council's 
next meeting on how they had implemented paragra ph 7 of the Decision, which was part of their 
obligations under Article 66.2.  He added that it w ould be useful if the Chair could prepare his own 
summary of the discussion. 
225. The representative of Mauritius, sp eaking on behalf of the ACP Group , supported India's 
recommendation to hold a dedicated workshop with th e participation of pharmaceutical companies, 
NGOs and other relevant actors.  Lessons drawn fro m experiences discussed at this meeting should be 
used to prepare the grounds to improve the System.  The implementation of practical solutions and the 
avoidance of ideological stances was important.  Wh ile alternatives to the System should be pursued, 
it should remain a main pillar to enable access to essential medicines, especially in times of 
pandemics and health crises.  He encouraged the WTO, WHO and WIPO to increase coordination, focusing more on flexibilities.  Their activities shoul d incorporate the regional perspective regarding  
the use such flexibilities with a vi ew to enabling access to medicines, and should also provide more 
targeted advice as opposed to general seminars. 
226. The representatives of Brazil, Venezuela, Ecua dor, Argentina, Peru, Chile, Egypt and China
 
supported India's recommendation that a dedicated work shop be held with an enlarged participation, 
including pharmaceutical companies and civil so ciety organizations.  The representative of Peru  also 
supported India's suggestion that the Chair prepare his own summary of the discussion. 
227. The representative of Canada  said that his delegation would be prepared to provide an update 
with respect to Bill C-393 in future Council meeti ngs.  His delegation had some ideas with respect to 
matters such as information dissemination and how it  could better publicize its work, particularly as  IP/C/57 
 Page 55 
 
 
  an exporting Member.  Some of this work dove tailed with other aspects of the Council's work, 
particularly under Articles 66.2 and 67 TRIPS.  He  invited Members who had not done so to respond 
to the questions raised by his delegation under th e first and second topics.  The Council had not yet 
met its full potential with respect to the engagement of Members, in terms of providing their specific 
national experiences.  He proposed that the Chair under take consultations in the near term to further 
explore some of these questions and how best to pr oceed.  He did not rule out the possibility of a 
workshop, but thought that more time was need ed to assess what had been done and to enable 
Members to provide responses.  His delegation was open to meet bilaterally, and would be happy to 
accept written responses and would welcome further input.   
228. The representative of the United States  associated his delegation with the points made by 
Canada.  The WTO was a Member-driven organization and the System was a Member-based solution.  
Members' experiences were therefore the most importa nt.  Before other stakeholders were brought in, 
it was incumbent upon the TRIPS Council to continue to  work through some of the issues.  He noted 
that, while the Council had heard from exporting Member s, it still needed to hear the experiences of 
potential importing Members, as the System had been d esigned for their benefit.  Therefore, there was 
no need for the Council to organize a workshop at this point.   
229. The representative of Australia  noted the absence of the voice of potential importing countries 
in the discussions, and the identification by such coun tries of obstacles or alternatives to the use of the 
System.  This would be an essential contribution that  would greatly facilitate the Council's work in its 
review of the System.  Her delegation supported Cana da's proposal that consultations on next steps be 
held by the Chair.  These could include holding a workshop, provided that it were sufficiently broad 
to allow meaningful and frank discussions of all the issues related to access to medicines.  The issues 
to be considered went beyond the narrow question of intellectual property rights and included aspects 
in the field of government procurement, supply chains and gender issues.   
230. The representative of Japan  requested further information from potential importers and in that 
regard supported the delegations of Ca nada, Australia and the United States with respect to next steps.   
231. The representative of India  reiterated his request for a dedicated workshop which could 
probably feed into the Member-driven discussions at the Council's next meeting.  Even in a Member-
driven organization like the WTO, there was scope for presentations and workshops involving 
external stakeholders.  For example, the US delega tion had in the past requested to have a workshop 
held by Caterpillar in the NAMA negotiations.  An  open-ended workshop befo re the Council's next 
meeting would further enrich discussions at that meeting.   
232. The representative of the European Union  said that more feedback from potential importing 
countries as to why they had not used the System thus far would be useful.  While not perfect, the System offered a mechanism that could be helpful to developing countries in getting medicines they 
needed.  He supported India's suggestion that the Chair conduct further consultations to discuss next 
steps.   
233. The representative of Switzerland
 regretted the absence of interventions from potential 
importing countries on potential concerns  or obstacles they may have met when wanting to make use 
of the System.  He supported the suggestion that delegations respond to outs tanding questions at the 
Council's next meeting.  His delegation was also in terested in being associated with any informal 
consultations the Chair might conduct.   
234. The representative of Mexico  said that it would be useful to receive in writing information 
about the experience of national pharmaceutical  sectors, including multinational pharmaceutical 
companies.  He also wished to be associated with any informal consultations the Chair might conduct.   IP/C/57 
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  235. The Chairman
 said that he had found the discussion of the topics under the annual review 
very useful.  As to next steps, there were two dis tinct views.  Some delegations were in favour of a 
workshop with an enlarged participation, while others believed that the Member-to-Member process 
had not yet been exhausted.  As recommended by a number of delegations, he suggested that he 
consult on follow-up to the review, including both the question of a workshop and other proposals 
made.   
236. The Council took note  of the statements made and so agreed . 
237. Turning to the Council's report to the General Council on the Annual Review of the Decision 
on the Implementation of Paragraph 6 of the Doha  Declaration on the TRIPS Agreement and Public 
Health, the Chairman recalled that the WTO Secretar iat had prepared a draft cover note to this report 
(JOB/IP/1).  It contained factual information on the implementation and use of the System established 
under the Decision, on discussions earlier in the y ear regarding its operation, and on the acceptance of 
the Protocol Amending the TRIPS Agreement.  He proposed that, in accordance with the way that the 
Council had prepared its report in previous years, th e part of the Minutes of the meeting reflecting the 
discussions held under this agenda item be a ttached to the cover note as an annex.   
238. As he had noted under item A, Croatia had just notified its amended Patent Act which 
implemented the System.  In addition, Albania ha d notified its new Law on Industrial Property, which 
also implemented the System.  Therefore, Croatia and Albania would be added to the list of Members 
who had notified their domestic implementation, c ontained in paragraph 4 of the draft cover note.  
Furthermore, Uganda had notified its  acceptance of the Protocol and would, therefore, be added to the 
list of Members in paragraph 12 of the draft cover note. 
239. The delegation of Canada  requested that some minor changes be made to the draft report, 
which had been submitted to the Secretariat.  Specifically, he suggested that the sentence in 
paragraph 8 of that report readi ng "The delegation of Canada shar ed its experience in using the 
System, including a detailed timeline of events" be re moved, and the subsequent sentence modified to 
read "Some delegations expressed concern that th e System had only been used once since 2003 and 
that it had taken some three years to deliver the me dicines from Canada to Rwanda in this context".  
He suggested that the following sentence remain  the same, and suggested inserting a subsequent 
sentence which would read:  "The delegation of Canada shared its experience in using the system, 
including a detailed timeline of events which, it its view, demonstrated the fact that Canada's access to 
medicines regime CAMR had been successfully uti lized and only a very small portion of this three-
year time period had been taken up by procedures associated with that regime.  It said that much of 
the time that elapsed between the regulatory review of the medicine in question and the shipping to 
Rwanda could be attributed to other variables". 
240. The representative of China  asked whether its amended Patent Act could be added to the draft 
cover note in the section listing Members who had notified their implementing legislation to the 
Council, if notified to the Council by the end of November.   
241. The Chairman  proposed that the Council agree to the cover note to the report as contained in 
JOB/IP/1, together with the updated information concerning Croatia, Albania and Uganda and the 
changes suggested by Canada, and also that the Council minutes containing the record of the discussion be attached thereto.  In addition, he proposed that the cover note be updated to include a 
reference to China's amended Patent Act,  provided that it was notified in time. 
242. The Council took note
 of the statements made and so agreed . 
 
__________